Freya Pharma Solutions at the 25th ESSM Congress
The Chief Medical Officer of Freya Pharma Solutions, Jan van der Mooren, attended the 25th European Society for Sexual Medicine (ESSM) congress in Italy in February. There he had the opportunity to share and learn from a wide range of specialists in sexual medicine. Read his thoughts below:
The ESSM 2024 congress in Bari, Italy, was undoubtedly, a great success!
As their Chief Medical Officer, I am very proud to have represented Freya Pharma Solutions as one of the Premium Partners of the congress, where we sponsored a very well attended round table on “Low desire from a female, male and couple perspective”, with presentations from internationally renowned speakers Prof. Annamaria Giraldi, Prof. Cobi Reisman, Dr. Marieke Dewitte, and Dr. Shelly Varod, and chaired by Prof. Giovanni Corona and Dr. Elisa Maseroli.
Freya Pharma’s innovation Lybrido™, a dual release combination tablet containing testosterone for sublingual administration, and sildenafil for oral administration, was presented as a very promising future treatment for women diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD) or Hypoactive Sexual Desire Disorder (HSDD). It was very encouraging to experience from the healthcare practitioners involved in the care of women suffering from FSIAD/HSDD, how much they embrace the development and future launch of Lybrido™ in a market with no registered drugs in Europe and only two drugs available in the USA. The latter having an efficacy/tolerance profile that is questioned by many.
I look forward to meeting you at the ESSM congress in Vienna next year, where we will update you on the progress of our upcoming confirmatory clinical trial ALETTA, testing Lybrido™ in premenopausal women diagnosed with acquired, generalized FSIAD, in Europe.
Follow us on LinkedIn to keep up to date with the team, Lybrido™, and the upcoming confirmatory clinical trial ALETTA.
Freya Pharma Solutions Announces Response from the FDA on its US Clinical Development Program of Lybrido for the treatment of Female Sexual Interest/Arousal Disorder
Amsterdam, the Netherlands, 19 June 2023 – Freya Pharma Solutions, a pharmaceutical company dedicated to developing effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders (FSD), announced today that the United States (US) Food and Drug Administration (FDA) has responded with interest and provided valuable input regarding Freya Pharma’s request for advice on the US Clinical Development Program of LybridoTM for the treatment of Female Sexual Interest/Arousal Disorder (FSIAD).
After receiving guidance from the European Medicines Agency (EMA) in September 2022, Freya Pharma Solutions is currently preparing for the ALETTA confirmatory clinical trial as part of the clinical development program of LybridoTM in Europe. The ALETTA trial is scheduled to commence in early 2024. In parallel, Freya Pharma has collaborated closely with its Scientific Advisory Board, which comprises renowned experts in the field of Female Sexual Disorders (FSD) from both the US and Europe, to design a clinical development program for the United States. The aim is to support a future Marketing Authorization Application (MAA) for LybridoTM in the US. In response to Freya Pharma’s request for advice, the FDA has shown keen interest and provided valuable guidance for the company’s clinical development program of LybridoTM.
Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions said:
“The response from the FDA regarding Freya Pharma’s clinical development program for LybridoTM in the US fills me with optimism, as it suggests we are moving in the right direction to bring LybridoTM to the market, and make a meaningful impact on the lives of numerous women affected by FSD. The FDA conducted a thorough review of our program, and provided clear answers to our questions. Additionally, the Agency offered invaluable advice on study designs, which we will gratefully incorporate into our program. I am confident that these inputs will enhance the quality of our clinical trials, and improve the likelihood of a successful outcome, which is essential before launching LybridoTM in the market. It is evident that there is a significant unmet need among women grappling with FSD for effective and safe treatments, currently lacking in Europe and very limited in the US. LybridoTM is expected to address this pressing need. Freya Pharma is highly assured that we are well on track with the clinical development of LybridoTM as a treatment for women experiencing sexual disorders and the associated distress that often adversely impacts their quality of life and relationships.”
About Female Sexual Disorders
Among female sexual disorders (FSD), low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional well-being. Currently, several definitions are being used. Hypoactive Sexual Desire Disorder (HSDD) is the definition recommended by ISSWSH and is a sexual disorder in which women lack motivation or lose desire to have sex for at least six months, causing significant levels of personal distress. Female Sexual Interest/Arousal Disorder (FSIAD) is a sexual disorder that is defined in the 2013 version of the DSM-5 – the Diagnostic and Statistical Manual of Mental Disorders – a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Persons can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.
About LybridoTM
A total of 20 phase 1 and phase 2a trials, and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on- demand pharmacological treatments that have been designed to treat two FSIAD subgroups: women with low sensitivity for sexual cues (LybridoTM) and women with dysfunctional over-activation of sexual inhibition (LybridosTM). LybridoTM increases central sexual motivation and physiological sexual responses, such as swelling of genitals and lubrication. The therapy can be taken ‘on-demand’ and helps to increase central sexual motivation from 3 to 6 hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet, consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-immediate-release matrix to ensure that the peak plasma concentration of the PDE 5 inhibitor coincides with the window of increased sexual motivation induced by the sublingually-administered testosterone. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a pharmaceutical company, focused on developing effective pharmaceutical therapies for FSIAD/HSDD, building upon fifteen years of solid research. The company has two compounds in development, LybridoTM and LybridosTM, to address the range of potential causes of FSIAD/HSDD. Based in Amsterdam, The Netherlands, Freya Pharma aims to offer patients a convenient, personalized ‘on-demand’ solution for this recognized unmet medical need.
For further information please contact:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Chief Executive Officer
marcel@freyapharmasolutions.com
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions Announces Advice from the FDA on its US Clinical Development Program of Lybrido for the treatment of Female Sexual Interest/Arousal Disorder
Amsterdam, the Netherlands, 9 May 2023 – Freya Pharma Solutions, a pharmaceutical company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders (FSD), announced today that the United States (US) Food and Drug Administration (FDA) has informed Freya that they will provide a written response by 4 June on the request for advice on the US Clinical Development Program of LybridoTM for the treatment of Female Sexual Interest/Arousal Disorder (FSIAD).
After obtaining advice from the European Medicines Agency (EMA) in September 2022, Freya Pharma Solutions is currently preparing the confirmatory ALETTA trial as part of the clinical development program of LybridoTM in Europe. As a next step Freya has designed a clinical development program for the US in close collaboration with its Scientific Advisory Board consisting of leading experts in the field of FSD from the US and Europe, to prepare for a Marketing Authorization Application (MAA) of LybridoTM in the US. On Freya’s request for advice, the FDA has now planned to provide a written response by 4 June 2023, where Freya’s objective is to reach an agreement with the agency regarding the clinical development program of LybridoTM in the US.
Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions said:
“The announced response from the FDA on our clinical development program for LybridoTM in the US marks a major next step in our plans to bring LybridoTM to the market, and to make a contribution to the lives of many women suffering from FSD. It can be concluded that there is a high unmet need among women suffering from FSD for effective and safe treatments, which are currently not available in Europe and are very limited in the US, and that LybridoTM is expected to address such a need. The ALETTA confirmatory clinical trial is planned to start soon in Europe, and we hope that with the advice from the FDA we can also soon start preparing clinical trials in the US. The company is highly confident that it is well on track with the clinical development of LybridoTM as a treatment for women suffering from sexual disorders and the related distress which often negatively interferes with their quality of life and their relationships.”
About Female Sexual Disorders
Among female sexual disorders (FSD), low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional well-being. Currently, several definitions are being used. Hypoactive Sexual Desire Disorder (HSDD) is the definition recommended by ISSWSH and is a sexual disorder in which women lack motivation or lose desire to have sex for at least six months, causing significant levels of personal distress. Female Sexual Interest/Arousal Disorder (FSIAD) is a sexual disorder that is defined in the 2013 version of the DSM-5 – the Diagnostic and Statistical Manual of Mental Disorders – a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Persons can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.
About Lybrido
A total of 20 phase 1 and phase 2a trials, and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on- demand pharmacological treatments that have been designed to treat two FSIAD subgroups: women with low sensitivity for sexual cues (LybridoTM) and women with dysfunctional over-activation of sexual inhibition (LybridosTM). LybridoTM increases central sexual motivation and physiological sexual responses, such as swelling of genitals and lubrication. The therapy can be taken ‘on-demand’ and helps to increase central sexual motivation from 3 to 6 hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet, consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-immediate-release matrix to ensure that the peak plasma concentration of the PDE 5 inhibitor coincides with the window of increased sexual motivation induced by the sublingually administered testosterone. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a pharmaceutical company, focused on developing effective pharmaceutical therapies for FSIAD/HSDD, building upon fifteen years of solid research. The company has two compounds in development, LybridoTM and LybridosTM, to address the range of potential causes of FSIAD/HSDD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized ‘on-demand’ solution for this recognized unmet medical need.
Please contact for further information:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Chief Executive Officer
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions appoints Christa van Kan as Director Clinical Operations, governing the company’s upcoming confirmatory clinical development program using Lybrido against FSIAD
Amsterdam, The Netherlands, 8 March 2023 – Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders (FSD), announced today the appointment of Christa van Kan, MSc (picture below) to the position of Director Clinical Operations, starting in March 2023. Ms. van Kan brings more than 25 years of clinical operations and trial management experience to Freya Pharma Solutions.
Marcel Wijma, CEO at Freya Pharma Solutions said:
“Christa possesses more than 25 years of experience in the contract research organization (CRO) industry. As our newly appointed Director Clinical Operations, she will be responsible for driving the confirmatory clinical development of our FSD therapy platform. During her impressive career, Christa has led numerous clinical programs from ‘first-in-human’ to Phase 3, managing performance targets to meet company goals, maintain resources, and coordinate process development to ensure optimal trial outcomes. We are delighted that Christa is joining Freya’s senior team as we prepare to initiate our confirmatory clinical trial, investigating LybridoTM, an ‘on demand’ therapy for the treatment of premenopausal women suffering from Female Sexual Interest/Arousal Disorder (FSIAD).”
Ms. van Kan was most recently Interim Director Clinical Operations at Healx, a Cambridge (UK) based AI drug discovery company, overseeing all clinical projects performed by the company and training and coaching the clinical team members. Prior to Healx, Ms. van Kan was co-founder in 1998 and Director Clinical Operations of PSR Group, a Dutch CRO. Ms. van Kan holds an MSc degree in Biomedical Sciences from the State University Leiden in The Netherlands.
Christa van Kan, MSc, Freya’s new Director Clinical Operations, commented:
“I am excited to join Freya at a pivotal time for the company as we plan to soon advance LybridoTM into a confirmatory clinical trial for the treatment of FSIAD. I look forward to working with Freya’s leadership and R&D team as we seek to transform the lives of women living with this severe sexual disorder by developing novel treatments that open new pathways to target lack of sexual interest and desire, with the overarching goal of improving their sexual health.”
Freya Pharma Solutions is currently preparing the clinical development program with several studies with LybridoTM in Europe, to be followed later by trials in the United States. In September 2022, Freya received early scientific advice from the European Medicines Agency (EMA) on its upcoming confirmatory ALETTA clinical trial, providing constructive and valuable elements that will contribute to the successful development of the therapy. The company is highly confident that it is well on track with the clinical development of LybridoTM as a treatment for women suffering from sexual dysfunction, and the related distress which often negatively impacts their quality of life and their relationships.
About Female Sexual Disorders
Among female sexual disorders, low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional well-being. Currently, several definitions are being used. Hypoactive Sexual Desire Disorder (HSDD) is recommended by ISSWSH and is a sexual dysfunction in which women lack motivation or lose desire to have sex for at least six months, causing significant levels of personal distress.
Female Sexual Interest/Arousal Disorder (FSIAD) is a sexual dysfunction that is defined in the 2013 version of the DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Persons can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.
About LybridoTM
A total of 20 phase 1 and phase 2a trials, and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments that have been designed to treat two FSIAD subgroups: premenopausal women with low sensitivity for sexual cues (LybridoTM) and women with dysfunctional over-activation of sexual inhibition (LybridosTM). LybridoTM increases central sexual motivation and physiological sexual responses. The therapy can be taken ‘on demand’ and helps to increase sexual desire and arousal from 3 to 6 hours after intake.
This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet consisting of a testosterone coating for sublingual administration and an inner-core component made of the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed immediate release matrix to ensure that the peak plasma concentration of the PDE 5 inhibitor coincides with the window of increased sexual motivation induced by the testosterone. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a late clinical stage company focused on developing effective pharmaceutical therapies for FSIAD, building upon fifteen years of solid research. The company has two compounds in development, Lybrido and Lybridos, to address the range of potential causes of FSIAD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized ‘on demand’ solution for this recognized unmet medical need.
Please contact for further information:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Chief Executive Officer
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions’ innovative compound Lybrido for the treatment of Female Sexual Disorders well received at European Society for Sexual Medicine Congress
Amsterdam, the Netherlands, 22 February 2023 – Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders (FSD), announced today that participants of the European Society for Sexual Medicine (ESSM) Congress, held 16 – 18 February, 2023, in Rotterdam, The Netherlands, showed great interest in Freya’s innovative drug candidate LybridoTM.
The ESSM congress was attended by around 700 participants from 59 countries around the world representing a broad range of sexual health practitioners. The design for the confirmatory ALETTA clinical trial was presented by Professor Cobi Reisman, member of Freya’s Scientific Advisory Board and urologist, sexologist, lecturer, honorary professor, and currently medical director of Flare-Health institute in Amstelveen, the Netherlands.
Furthermore, during a very well attended round table discussion entitled “Hypoactive Sexual Desire in young women: What women want” conversations took place among key experts in the field. Professor Linda Vignozzi, Professor Annamaria Giraldi, Dr. Shelly Varod, Dr. Giovani Corona, and Professor Cobi Reisman referred to LybridoTM as a promising innovative treatment for women suffering from FSD. From the many questions and discussions that followed the experts’ presentations, it can be concluded that there is a high unmet need among women suffering from FSD for effective and safe treatments, which are currently not available in Europe, and that LybridoTM is expected to address such a need.
Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions said:
“I was delighted to experience such positive feedback on LybridoTM from so many sexual health experts and practitioners. Even though we must await the results of the upcoming clinical trials in Europe and the United States before women will have access to LybridoTM, the results from the phase 2 clinical trials have already been very promising, showing positive efficacy results without indications for safety concerns. The ALETTA Confirmatory Clinical Study is planned to start soon in Europe, and we hope to receive advice from the FDA on our Clinical Development Plan for the United States in spring this year.”
Freya Pharma Solutions is currently preparing the clinical development program of LybridoTM with several studies in Europe, to be followed later by additional trials in the United States. In September 2022, Freya received early scientific advice from the European Medicines Agency (EMA) on its upcoming confirmatory ALETTA clinical trial, providing constructive and valuable elements that will contribute to the successful development of the therapy. The company is highly confident that it is well on track with the clinical development of LybridoTM as a treatment for women suffering from sexual dysfunction and the related distress which often negatively interferes with their quality of life and their relationships.
About Female Sexual Disorders
Among female sexual disorders, low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional well-being. Currently, several definitions are being used. Hypoactive Sexual Desire Disorder (HSDD) is recommended by ISSWSH and is a sexual dysfunction in which women lack motivation or lose desire to have sex for at least six months, causing significant levels of personal distress. Female Sexual Interest/Arousal Disorder (FSIAD) is a sexual dysfunction that is defined in the 2013 version of the DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Persons can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.
About LybridoTM
A total of 20 phase 1 and phase 2a trials and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on- demand pharmacological treatments that have been designed to treat two FSIAD subgroups: women with low sensitivity for sexual cues (LybridoTM) and women with dysfunctional over-activation of sexual inhibition (LybridosTM). LybridoTM increases central sexual motivation and physiological sexual responses, such as swelling of genitals and lubrication. The therapy can be taken ‘on-demand’ and helps to increase central sexual motivation from 3 to 6 hours after intake.
This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet, consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-immediate-release matrix to ensure that the peak plasma concentration of the PDE 5 inhibitor coincides with the window of increased sexual motivation induced by the sublingually administered testosterone. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a late clinical stage company focused on developing effective pharmaceutical therapies for HSDD/FSIAD, building upon fifteen years of solid research. The company has two compounds in development, LybridoTM and LybridosTM, to address the range of potential causes of HSDD/FSIAD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized ‘on-demand’ solution for this recognized unmet medical need.
Please contact for further information:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Chief Executive Officer
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions extends its Scientific Advisory Board with USA-based international leading experts in the field of Female Sexual Disorders
Dr. Irwin Goldstein, Sue Goldstein, Prof. Sheryl Kingsberg, and Dr. Rachel Rubin
Amsterdam, the Netherlands, 10 February 2023 – Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders (FSD), today announced the extension of its Scientific Advisory Board (SAB) with four independent leading medical scientists in the FSD field from the US: Dr. Irwin Goldstein, Sue Goldstein, Prof. Sheryl Kingsberg, and Dr. Rachel Rubin. The extension was established in the light of the start of preparations for Freya’s clinical development program for LybridoTM against Female Sexual Disorders in the United States. The first meeting with the new members took place on 4 February 2023 in Houston, US. The SAB is chaired by Freya’s Chief Medical Officer Dr. Jan van der Mooren.
In 2022 Freya announced the initiation of its SAB with experts from Europe: Prof. Annamaria Giraldi, Prof. Rossella Nappi, Prof. Cobi Reisman, Prof. Linda Vignozzi and Dr. Giovanni Corona, to design the European clinical program. The US members have been installed to further shape this highly important advisory body for the company. The SAB co-designs the clinical program for LybridoTM overseeing that the quality of research at Freya is maintained, as well as assessing its upcoming confirmatory clinical trials with LybridoTM.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:
“I am delighted that leading experts in the field of Female Sexual Disorders from the United States have now joined our Scientific Advisory Board. As most of them have been involved in the early phase studies of LybridoTM, I trust that with their help we will be able to successfully design a compelling clinical trial program that will meet the requirements of the FDA. We intend to submit our plans to the FDA soon.”
During the meeting on 4 February 2023, the SAB together with the Lybrido Clinical Project Team discussed the European clinical program to confirm the efficacy of LybridoTM in women suffering from Female Sexual Disorders, and they worked together on drafting the US clinical program that is expected to be presented to FDA this spring.
Scientific Advisory Board
The new members of the Scientific Advisory Board are:
Dr. Irwin Goldstein MD, IF
Dr. Goldstein is Director of Sexual Medicine at Alvarado Hospital, Clinical Professor of Surgery and Voluntary Clinical Professor of Obstetrics, Gynecology, & Reproductive Sciences at University of California San Diego, and practices medicine at San Diego Sexual Medicine. He is also Editor-in-Chief of Sexual Medicine Reviews and past Editor of The Journal of Sexual Medicine. He is a past President of the International Society for the Study of Women’s Sexual Health (ISSWSH) and of the Sexual Medicine Society of North America (SMSNA). Dr. Goldstein has authored more than 350 publications as well as multiple book chapters and edited 6 textbooks in the field.
Sue Goldstein BA, CCRC, AASECT-CSE, IF
Mrs. Goldstein is an AASECT Certified Sexuality Educator and Clinical Research Manager at San Diego Sexual Medicine. She works with the staff of the Sexual Medicine program at Alvarado Hospital and works with regional support groups. Mrs. Goldstein is currently President of the International Society for the Study of Women’s Sexual Health (ISSWSH) and serves on the Scientific Review Committee of the International Society for Sexual Medicine (ISSM) as well as the Educational Projects, Fellowship and Female Sexual Function Committees of the Sexual Medicine Society of North America (SMSNA). Mrs. Goldstein is managing editor of Sexual Medicine Reviews, and she is associate editor of Textbook of Female Sexual Function and Dysfunction and Female Sexual Pain Disorders. She co-authored When Sex Isn’t Good and is author of multiple peer reviewed papers.
Prof. Sheryl Kingsberg, PhD
Professor Sheryl Kingsberg is Chief of the Division of Behavioral Medicine in the Department of Obstetrics & Gynecology at University Hospitals Cleveland Medical Center/MacDonald Women’s Hospital in Cleveland, and a Professor in the Departments of Reproductive Biology, Psychiatry and Urology at Case Western Reserve University School of Medicine. She is a past President of The North American Menopause Society and The International Society for the Study of Women’s Sexual Health (ISSWSH). Prof. Kingsberg is Associate Editor of Sexual Medicine Reviews, and has (co-) authored more than 160 scientific papers and books/book chapters.
Dr. Rachel Rubin MD, IF
Dr. Rachel Rubin is a Board Certified Urologist and Sexual Medicine Specialist, and Assistant Clinical Professor at the Department of Urology at Medstar Georgetown University. She is Associate Editor of Sexual Medicine Reviews, a reviewer of The Journal of Sexual Medicine, Section Editor for Female Sexual Medicine, and a reviewer for America Urological Association guidelines on Ejaculatory Dysfunction. Dr. Rubin is a member of the board of directors of the International Society for the Study of Women’s Sexual Health (ISSWSH), a member of the American Urological Association (AUA), serves on the social media committee of the Sexual Medicine Society of North America (SMSNA), and is a member of the International Society for Sexual Medicine (ISSM). She is an active social media educator on FSD, has (co-)authored multiple scientific papers and authored 4 book chapters.
Dr. Jan van der Mooren MD, PhD, MSc is Chairman of the SAB and Chief Medical Officer of Freya Pharma Solutions.
About Female Sexual Disorders
Among female sexual disorders, low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional wellbeing. Currently several definitions are being used. Hypoactive Sexual Desire Disorder (HSDD) is recommended by ISSWSH and is a sexual dysfunction in which women lack motivation or lose desire to have sex for at least six months, causing significant levels of personal distress. Female Sexual Interest/Arousal Disorder (FSIAD) is a sexual dysfunction that is defined in the 2013 version of the DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Persons can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.
About LybridoTM
A total of 20 phase 1 and phase 2a trials and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments that have been designed to treat two FSIAD subgroups: women with low sensitivity for sexual cues (LybridoTM) and women with dysfunctional over-activation of sexual inhibition (LybridosTM). LybridoTM increases central sexual motivation and physiological sexual responses, such as swelling of genitals and lubrication. The therapy can be taken ‘on-demand’ and helps to increase central sexual motivation from 3 to 6 hours after intake.
This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet, consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-immediate-release matrix to ensure that the peak plasma concentration of the PDE 5 inhibitor coincides with the window of increased sexual motivation induced by the sublingually administered testosterone. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a late clinical stage company focused on developing effective pharmaceutical therapies for HSDD/FSIAD, building upon fifteen years of solid research. The company has two compounds in development, LybridoTM and LybridosTM, to address the range of potential causes of HSDD/FSIAD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized ‘on-demand’ solution for this recognized unmet medical need.
Please contact for further information:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Executive Director
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions appoints Nicole Hijnen as President of the Board, overseeing the company’s upcoming clinical development program with Lybrido against FSIAD
Amsterdam, the Netherlands, 1 February 2023 – Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women who have been diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), today announced the appointment of Nicole Hijnen, PhD (picture below) as President of Freya’s Board as per January 2023. Dr. Hijnen is a health scientist who held a variety of senior management positions within Philips Healthtech, most recently as Director – Business Leader Connected Care Benelux. Her appointment comes in a year where Freya is rolling out its final clinical development program, starting with the confirmatory ALETTA clinical trial with LybridoTM in premenopausal women with acquired FSIAD.
Marcel Wijma, CEO at Freya Pharma Solutions said:
“We are very pleased to have Nicole join Freya as President of our Board as we are on the brink of commencing our confirmatory clinical trial with our promising compound LybridoTM against FSIAD. She brings exactly the right blend of academic and operational healthtech experience to help guide Freya to the next phase. With her deep knowledge of evolving FemTech science and technology, as well as her views on galvanizing an impassioned patient community, Nicole possesses all the skills to help propel our vision – addressing the urgent unmet medical need of women worldwide suffering from FSIAD.”
In addition to bringing a wealth of experience from the healthtech industry at Philips, Dr. Hijnen has held a number of senior management and scientific positions worldwide. She obtained vast commercialization experience in the medical device industry and has a deep understanding of the EU and US markets. Within Philips she brought new medical devices to the US market among others, being responsible for end-to-end design, FDA approval, and sales, including claim strategy and setup of sales channels.
Dr. Hijnen obtained her MSc in Biomedical Engineering at TU – Eindhoven and her PhD in magnetic resonance-guided high intensity focused ultrasound for non-invasive thermal cancer therapy at TU – Eindhoven and Philips. Currently, she is a non-executive board member of the medical company SyncVR Medical. She is also an active investor in food and healthcare companies and participates in Arches Capital in Amsterdam, a group of business angels bridging the gap between Venture Capital companies (VCs) and business angels by connecting knowledge with capital.
Nicole Hijnen, PhD, new President of Freya’s Board, commented:
“I am excited to be joining Freya as President of the Board. I look forward to working with Freya’s excellent leadership team. Our goal is to empower women worldwide to own their sexual health, which is fundamental to the overall health and well-being of individuals, couples and families. The scientific progress is there – women may enjoy its benefits! Freya has a strong, intelligent concept with a formulation of two compounds that have been shown to be safe and effective in a compelling clinical phase 2 trial, successfully improving sexual desire and arousal. I see great potential and look forward to really making a difference by overseeing the preparations for and execution of the decisive confirmatory ALETTA trial with LybridoTM.”
Freya Pharma Solutions is currently preparing the clinical development program with several studies with LybridoTM in Europe, to be followed later by additional trials in the United States. In September 2022, Freya received early scientific advice from the European Medicines Agency (EMA) on its upcoming confirmatory ALETTA clinical trial, providing constructive and valuable elements that will contribute to the successful development of the therapy. The company is highly confident that it is well on track with the clinical development of LybridoTM as a treatment for women suffering from sexual dysfunction, and the related distress which often negatively interferes with their quality of life and their relationships.
About FSIAD
Low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional wellbeing. FSIAD is a sexual dysfunction that is defined in the 2013 version of the DSM-V Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Women can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.
About Lybrido
A total of 20 phase 1 and phase 2a trials, and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments that have been designed to treat two FSIAD subgroups: women with low sensitivity for sexual cues (LybridoTM) and women with dysfunctional over-activation of sexual inhibition (LybridosTM). LybridoTM intends to increase central sexual motivation and physiological sexual responses. The therapy can be taken ‘on demand’ and helps to increase sexual desire and arousal from 3 to 6 hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet containing a testosterone coating for sublingual administration and an inner-core component made of the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed immediate release matrix to ensure that the peak plasma concentration of the PDE 5 inhibitor coincides with the window of increased sexual motivation induced by the testosterone. This combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a late clinical stage company focused on developing effective pharmaceutical therapies for FSIAD, building upon fifteen years of solid research. The company has two compounds in development, Lybrido and Lybridos, to address the range of potential causes of FSIAD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized ‘on demand’ solution for this recognized unmet medical need.
Please contact for further information:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, CEO
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions: ALETTA Pivotal Trial Well Received at ISSM/SMSNA Scientific Meeting
Amsterdam, the Netherlands, 4 November 2022 – Freya Pharma Solutions, a late clinical stage
pharmaceutical company focusing on the development of effective pharmaceutical therapies for
women diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), has presented the design of
its upcoming ALETTA pivotal clinical trial with LybridoTM at the 23rd ISSM/SMSNA Scientific Meeting.
The International Society for Sexual Medicine (ISSM) Scientific Meeting & 23rd Annual Fall Scientific
Meeting of Sexual Medicine Society of North America (SMSNA), was held late October 2022 in Miami
Beach, Florida. The paper titled “Design of the ALETTA Clinical Study: A Randomized Double-Blind
Placebo-Controlled Study investigating the Efficacy and Safety of LybridoTM in Premenopausal Women
with Acquired FSIAD”, was presented by first author Dr. Cobi Reisman and got a warm scientific
reception by attending health professionals from all over the world.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:
“Presenting our ALETTA trial at this conference is an important step in acquiring feedback from an
audience of international professionals in sexual medicine on our clinical development plans. The
abundance of positive comments confirms our belief that there is a great unmet need for an
effective treatment of female sexual problems, and that LybridoTM has the potential to fill in that
gap. The concept of LybridoTM, creating a unique synergy of testosterone and sildenafil, is
recognized by international experts as an innovative drug on a market with only two approved
drugs for FSIAD in the United States, while no drug being approved in Europe so far.”
Freya Pharma Solutions is currently preparing the clinical development program with several studies
in Europe, to be followed later by additional trials in the United States. The company is highly confident
that it is well on track with the clinical development of LybridoTM as a treatment for women suffering
from sexual dysfunction, and the related distress which often negatively interferes with their quality
of life and their relationships.
About FSIAD
Low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional wellbeing. FSIAD is a sexual dysfunction that is defined in the 2013 version of the DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Persons can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.
About Lybrido
A total of 20 phase 1 and phase 2a trials and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments that have been designed to treat two FSIAD subgroups: women with low sensitivity for sexual cues (Lybrido) and women with over-activation of sexual inhibition (Lybridos). Lybrido increases central sexual motivation and physiological sexual responses, such as swelling of vaginal erectile tissue and lubrication. The therapy can be taken ‘on demand’ and helps to increase central sexual motivation from three to six hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-release matrix to ensure that the peak plasma concentration of the sildenafil coincides with the window of increased sexual motivation induced by the testosterone component. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a late clinical stage company focused on developing effective pharmaceutical therapies for FSIAD, building upon fifteen years of solid research. The company has two compounds in development, Lybrido and Lybridos, to address the range of potential causes of FSIAD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized ‘on demand’ solution for this recognized unmet medical need.
Please contact for further information:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Chief Executive Officer
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions Receives Early EMA Scientific Advice on its upcoming Phase 3 Clinical Trial to Confirm Efficacy of Lybrido in Women Suffering From FSIAD
Amsterdam, the Netherlands, 28 September 2022 – Freya Pharma Solutions, a late clinical stage pharmaceutical company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), today announced the receipt of early European Medicines Agency (EMA) scientific advice on its upcoming pivotal phase 3 clinical trial (the ALETTA trial), investigating Lybrido for the treatment of FSIAD. The EMA Committee for Medicinal Products for Human Use (CHMP) came to its conclusions within the short, 40-day evaluation phase, without necessitating a discussion meeting for further clarification. Freya will now implement the adjustments as recommended by the EMA in its clinical development program for Lybrido.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:
“I am very happy with this early EMA scientific advice, as it represents an important milestone in the development program for Lybrido. The EMA advice holds very constructive and valuable elements that will contribute to the successful development of our therapy. It also strengthens our understanding of how to further design the clinical program to ensure a timely launch of Lybrido on the European market. Following the short procedure, Freya is still well on track with its planning of the ALETTA trial. Lybrido is an innovative drug in a market with very few approved drugs in the United States, and no drug being approved in Europe so far.”
Together with the expert support of the members of the Scientific Advisory Board, Freya will implement the adjustments as recommended by the EMA in the clinical development program of Lybrido. The initial focus will be on the study protocol of the ALETTA trial, a randomized placebo-controlled phase 3 clinical trial to demonstrate the efficacy and safety of Lybrido. Clinical research organization CR2O BV (www.CR2O.nl) is leading the preparation, execution, and reporting of this trial.
Freya Pharma Solutions is currently preparing the first phase 3 clinical trial in Europe as part of a clinical development program with several studies in Europe, to be followed later by additional trials in the United States. The company is highly confident that it is well on track with the clinical development of Lybrido as a treatment for women suffering from sexual dysfunction, and the related distress which often negatively interferes with their quality of life.
About FSIAD
Low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional wellbeing. FSIAD is a sexual dysfunction that is defined in the 2013 version of the DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Persons can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.
About Lybrido
A total of 20 phase 1 and phase 2a trials and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments that have been designed to treat two FSIAD subgroups: women with low sensitivity for sexual cues (Lybrido) and women with over-activation of sexual inhibition (Lybridos). Lybrido increases central sexual motivation and physiological sexual responses, such as swelling of vaginal erectile tissue and lubrication. The therapy can be taken ‘on demand’ and helps to increase central sexual motivation from three to six hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-release matrix to ensure that the peak plasma concentration of the sildenafil coincides with the window of increased sexual motivation induced by the testosterone component. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a late clinical stage company focused on developing effective pharmaceutical therapies for FSIAD, building upon fifteen years of solid research. The company has two compounds in development, Lybrido and Lybridos, to address the range of potential causes of FSIAD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized ‘on demand’ solution for this recognized unmet medical need.
Please contact for further information:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Executive Director
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions Announced Further Strengthening of its IP Position for Improved Treatment for Women Suffering From FSIAD
Amsterdam, the Netherlands, 25 August 2022 – Freya Pharma Solutions, a late clinical stage pharmaceutical company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), today announced the filing of new patent applications for improved treatment of FSIAD.
Last year Freya Pharma Solutions acquired all Intellectual Property (IP) for two innovative drugs, Lybrido and Lybridos, developed for the treatment of women suffering from FSIAD. With the new patent applications announced today, Freya will significantly strengthen its IP position in this area, and add strong additional protection until 2042, thereby extending its value life cycle.
Upcoming pivotal phase 3 trial
Freya Pharma Solutions plans to conduct a pivotal phase 3 clinical trial to confirm the efficacy and safety of Lybrido in women suffering from FSIAD. In June this year, a clinical trial application was submitted to the European Medicines Agency (EMA) for scientific advice on the upcoming phase 3 clinical trial with Lybrido for the treatment of FSIAD. The trial will be conducted within the European Union in accordance with Good Clinical Practices and the ethical principles stated in the Declaration of Helsinki. It will comply with the EU Clinical Trial Regulation (No. 536/2014), all other applicable laws and regulations, as well as requirements of applicable Member States where the study is undertaken.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:
“Lybrido is a unique therapeutic concept, both in its combination of testosterone and sildenafil, as well as in its dual route, dual release, fixed dose system, thereby achieving the optimal synergy of both active ingredients. Lybrido will be an innovative drug in a market with very few approved drugs in the United States, and no drug approved in Europe so far. With the new patent applications, Freya will further strengthen its IP position and provide strong protection for effective and safe treatment for women suffering from FSIAD.”
About FSIAD
Low sexual desire is consistently reported as the most common sexual complaint in women. As a result, many women are dissatisfied with their sex lives, which often affects their social and emotional wellbeing. FSIAD is a sexual dysfunction that is defined in the 2013 version of the DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as a persistent lack or significant reduction of sexual interest and/or arousal. Persons can be medically diagnosed after having a well-defined number of symptoms causing clinically significant distress and which have persisted for a minimum of six months. The disorder is specified by severity level and subtyped into lifelong versus acquired, generalized versus situational.
About Lybrido
A total of 20 phase 1 and phase 2a trials and large-scale phase 2b trials in 17 research sites in the US have been conducted to date. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments that have been designed to treat two FSIAD subgroups: women with low sensitivity for sexual cues (Lybrido) and women with over-activation of sexual inhibition (Lybridos). Lybrido increases central sexual motivation and physiological sexual responses, such as swelling of vaginal erectile tissue and lubrication. The therapy can be taken ‘on demand’ and helps to increase central sexual motivation from three to six hours after intake. This treatment consists of a novel (dual-route, dual-release, fixed-dose) combination tablet consisting of a testosterone coating for sublingual administration and an inner-core component containing the phosphodiesterase type 5 (PDE 5) inhibitor, sildenafil. The inner-core component is coated with a delayed-release matrix to ensure that the peak plasma concentration of the sildenafil coincides with the window of increased sexual motivation induced by the testosterone component. Thus, this combination enables an increase in genital arousal through an increase in responsivity to sexual stimuli.
About Freya Pharma Solutions
Freya Pharma Solutions is a late clinical stage company focused on developing effective pharmaceutical therapies for FSIAD, building upon fifteen years of solid research. The company has two compounds in development, Lybrido and Lybridos, to address the range of potential causes of FSIAD. Based in Amsterdam, The Netherlands, Freya aims to offer patients a convenient, personalized ‘on demand’ solution for this recognized unmet medical need.
Please contact for further information:
Freya Pharma Solutions, Amsterdam
Marcel Wijma, Executive Director
marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427