Freya Pharma Solutions Announced Its Application for EMA Scientific Advice on its Phase 3 Clinical Trial to Confirm Efficacy of Lybrido in Women Suffering From FSIAD
Amsterdam, the Netherlands, 29 June 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 submission of the trial protocol application with the European Medicines Agency (EMA) for scientific advice on the upcoming pivotal phase 3 clinical study with Lybrido for the treatment of FSIAD. Freya expects to receive the EMA scientific advice no later than October 2022. The phase 3 trial will start in late 2022/early 2023, with interim results expected by the second half of 2023.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:
“This application for EMA scientific advice is a major step in Freya’s development program for Lybrido, which is offering an effective and safe treatment for women suffering from FSIAD. Lybrido will be an innovative drug in a market with very few approved drugs in the United States, and no drug being approved in Europe so far.”
With great support of the members of the Scientific Advisory Board, Freya has drafted a thorough and detailed clinical study protocol of 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.
The trial has been given the short name “ALETTA”, referring to Aletta Henriëtte Jacobs, a Dutch physician and women’s suffrage activist. As the first woman to officially attend a Dutch university, she became one of the first female physicians in the Netherlands.
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, and later also in the United States. The company is highly confident that it is well on track with establishing 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 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-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
Freya Pharma Solutions establishes Scientific Advisory Board with leading European experts in the field of female sexual disorders; Prof. Annamaria Giraldi, Prof. Rossella Nappi, Prof. Cobi Reisman, Prof. Linda Vignozzi and Dr. Giovanni Corona
Report on the first meeting – contribution of the SAB to the pivotal phase 3 clinical trial protocol for Lybrido, to be finalized soon hereafter
Amsterdam, the Netherlands, 25 May 2022 – Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Interest/Arousal Disorder (FSIAD), today announced that on 30 April 2022 the first meeting of the newly installed Scientific Advisory Board (SAB) was held. The SAB, chaired by Freya’s Chief Medical Officer Jan van der Mooren, consists of five independent recognized medical scientists, which together shape a highly important advisory body for the company. The SAB sees to it that the quality of research at Freya is maintained and will oversee and assess its upcoming pivotal phase 3 clinical trial protocol and execution with Lybrido.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:
“The members of the Scientific Advisory Board are leading experts in the specific field of female sexual disorders. We are delighted to have such a strong group of individuals join our Scientific Advisory Board, providing us with objective, external perspective and quality authentication. They are thought leaders within this specific scientific community.”
During its first meeting on 30 April 2022, the SAB together with the Lybrido Clinical Project Team worked on drafting the protocol for the phase 3 clinical trial to confirm the efficacy of Lybrido in women suffering from FSIAD. The protocol is expected to be ready for obtaining EMA Scientific Advice this summer.
Scientific Advisory Board
Members of the newly formed Scientific advisory Board are:
Prof. Annamaria Giraldi MD, PhD, FECSM
Professor Annamaria Giraldi is Senior Consultant in Psychiatry in the Sexological Clinic at Psychiatric Center Copenhagen and Professor of Clinical Sexology at the University of Copenhagen, Denmark, where she also received her medical degree and PhD. Professor Giraldi has been involved in the field of sexual medicine for many years, educating medical students, nurses, physicians and psychologists in sexual medicine.
Prof. Rossella Nappi MD, PhD
Professor Rossella Nappi is Full Professor of Obstetrics and Gynaecology, Research Center for Reproductive Medicine and Director of the Reproductive Medicine, Gynaecological Endocrinology & Menopause Unit, IRCCS San Matteo Foundation, University of Pavia, Italy. Professor Nappi’s major interests are psycho-neuroendocrinology of female reproductive life and women’s sexuality. She has published around 350 scientific articles in peer-reviewed journals and international books with more than 18,000 citations.
Prof. Cobi Reisman MD, PhD, FCESM,ECPS
Professor Cobi Reisman is urologist, sexologist, lecturer, honorary professor, and currently medical director of Flare-Health institute in Amstelveen, the Netherlands, senior lecturer of Clinical Sexology at the postgraduate institute RINO-Amsterdam, Consultant at Reuth Rehabilitation Hospital Tel-Aviv and co-director of the European Society for Sexual Medicine (ESSM) School of Sexual Medicine. He has more than 20 years of clinical experience focusing on sexual dysfunctions in males and females. In 1998 he received his PhD thesis on diagnostic tools and objective medical decisions. Editors of the ESSM manual of sexual medicine and EFS-ESSM Syllabus of clinical sexology, Cancer and sexuality and Textbook of rare sexual medicine conditions.
Prof. Linda Vignozzi MD, PhD, FECSM
Professor Linda Vignozzi is Associate Professor in Endocrinology at the University of Florence, Department of Experimental and Clinical Biomedical Sciences where she coordinates the Gynaecological Endocrinology Research Unit in the Sexual Medicine and Andrology Unit. Professor Vignozzi has written several book chapters and invited reviews in the field of male and female sexual medicine, hypogonadism and metabolic diseases, prostatic diseases, including BPH, and human reproduction.
Dr. Giovanni Corona MD, PhD, FCESM
Dr. Giovanni Corona is endocrinologist and andrologist at the Endocrinology Unit of Maggiore-Bologna Hospital, Bologna, Italy. He received an MD degree at the University of Bologna and a Board in Endocrinology and Doctor of Philosophy degree at the University of Florence. He received two prestigious awards, one in 2009 from the European Society for Sexual Medicine, “Excellent Award” and the second in 2013 from the International Society of Andrology, the “Young Andrologist Award”. In 2015 he was quoted in the top best European 30 researchers (category “Reproductive Biomedicine” n=11) by Lab Times. He is co-author of over 250 peer-reviewed papers, different book chapters and invited reviews in the field of endocrinology and sexual medicine.
Dr. Jan van der Mooren MD, PhD, MSc, is Chairman of the SAB and Chief Medical Officer of Freya Pharma Solutions.
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 dysfunctional 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 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-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 sublingual 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, Executive Director
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions Announces Appointment of Dr. Jan van der Mooren as Chief Medical Officer, to guide its pivotal phase 3 clinical trial with Lybrido against FSIAD
Dr. van der Mooren brings three decades of experience in clinical trials
Amsterdam, the Netherlands, 12 April 2022 – 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 Jan van der Mooren MD, PhD, MSc (picture below) as Chief Medical Officer as per April 2022. Dr. van der Mooren is a medical doctor with additional education in Gynaecological Endocrinology and Epidemiology. He has been involved in clinical research since 1990. Prior to his appointment he was Senior Director of the Danone Nutricia Research Center in Utrecht, the Netherlands. Jan will be in the lead of Freya’s steering committee overseeing the upcoming phase 3 study of Lybrido to confirm its efficacy in women suffering from FSIAD.
Marcel Wijma, Executive Director at Freya Pharma Solutions said:
“We are very pleased to have Jan join our leadership team as we are on the brink of commencing our phase 3 clinical trial with our promising compound Lybrido, against FSIAD. His depth of experience in clinical trials and knowledge in the field of Gynaecological Endocrinology will be especially valuable during this pivotal time at the company,”
Dr. van der Mooren brings to Freya three decades of life sciences experience in clinical development and medical affairs in nutrition, epidemiology, obstetrics and gynaecology. Most recently he served as Senior Director R&I Governance, Communication & Excellence and Senior Director of the Nutricia Research Center in Utrecht. Prior to that he held several leading R&D positions within the Danone and Numico organisations, heading the Clinical Research in early life nutrition, advanced medical nutrition, fresh dairy products and waters since 2005. From 1995 until 2005 he was Associate Professor, Epidemiologist and project leader of “Ageing Women” at the Department of Obstetrics & Gynaecology of VU University Medical Center in Amsterdam. In addition to several other functions, he was Senior Researcher and Project Co-ordinator of the “Postmenopause Project” at Radboud University Hospital in Nijmegen, the Netherlands.
Dr. Jan van der Mooren, newly appointed CMO at Freya commented:
“I am excited to be joining Freya and look forward to working with the outstanding leadership team here in the pivotal trial phase of the company’s promising solution for millions of women worldwide who are coping with FSIAD, resulting in lower health-related quality of life, including more depressive symptoms, and lower sexual and relationship satisfaction.”
Upcoming pivotal phase 3 trial
Freya Pharma Solutions plans to conduct the pivotal phase 3 clinical trial to confirm the efficacy of Lybrido in women suffering from FSIAD. Previous pre-clinical and clinical studies, manufacturing and development of Lybrido were performed according to EU GLP, GMP and GCP regulations.
It is anticipated that a Scientific Advice Meeting with the EMA will be held before commencement of the phase 3 trial. The main objective of that meeting would be to confirm acceptability of the phase 3 clinical trial design, as well as the overall clinical development strategy. The phase 3 clinical 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.
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 dysfunctional 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 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-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 sublingual 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, Executive Director
E: marcel@freyapharmasolutions.com
For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
Freya Pharma Solutions secures US$8.5 million enabling the start of a pivotal phase 3 trial with Lybrido against Female Sexual Interest/Arousal Disorder (FSIAD)
- Proceeds to be used for a phase 3 registration enabling trial with Lybrido
- Funding from existing and new investors, reflecting great confidence in the candidate to be evaluated
- FSIAD is a type of sexual dysfunction and a recognized unmet medical need with very limited effective treatment options
Amsterdam, March 29, 2022 – 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 to have secured US$8.5 million in new funding from existing and new investors. The new funding will be used to carry out a pivotal phase 3 trial with its therapy Lybrido in 516 patients across Europe. Previously, Lybrido showed clinical relevance and statistical significance in a phase 2b clinical trial, clearly meeting the primary endpoints. The phase 3 trial will start in the second half of 2022, with interim results expected by the second half of 2023.
Upcoming pivotal phase 3 trial
Freya Pharma Solutions plans to conduct the pivotal phase 3 clinical trial to confirm the efficacy of Lybrido in women suffering from female sexual interest/arousal disorder (FSIAD). Clinical research Organization CR2O BV (www.CR2O.nl) is leading the preparation, execution and reporting of this Phase 3 clinical trial. CR2O is a full-service clinical contract research organization aimed at developing innovative treatments for unmet medical needs.
Previous pre-clinical and clinical studies, manufacturing and development of Lybrido were performed according to EU GLP, GMP and GCP regulations.
It is anticipated that a Scientific Advice Meeting with the EMA will be held before commencement of the phase 3 trial. The main objective of that meeting would be to confirm acceptability of the phase 3 trial design protocol, as well as the overall clinical development strategy.
The phase 3 clinical 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.
Marcel Wijma, Executive Director of Freya Pharma Solutions comments:
“We’re delighted with the trust and confidence from our existing and new shareholders in the chances of advancing this groundbreaking therapy for women with FSIAD to the market in due course. And we’re fully committed to bringing a therapy for FSIAD to a great number of patients around the world suffering from this distressing disorder.”
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 to investigate 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 dysfunctional 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 about 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 inhibitor sildenafil. The inner-core component is coated with a delayed-release matrix to ensure that the peak plasma concentration of the phosphodiesterase type 5 inhibitor coincides with the window of increased sexual motivation induced by the sublingual 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 female sexual interest/arousal disorder (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
E: lmelens@lifespring.nl
Freya Pharma Solutions to acquire all IP from Emotional Brain, giving opportunities to further examine pharmaceutical therapies for Female Sexual Interest/Arousal Disorder in a double blind, randomized phase 3 trial
Amsterdam, 17 December 2021 – 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 to have reached agreement with shareholders on the acquisition of all intellectual property (IP), including all know-how and prior clinical trial results, for two therapies against FSIAD in clinical development, from Dutch Emotional Brain BV (EB).
Freya Pharma has been established to further advance two compounds for the FSIAD-disorder, Lybrido and Lybridos, that have shown to be clinically relevant and statistically significant in an earlier phase 2b clinical trial, clearly meeting the primary endpoints. Freya is examining the possibilities for a clinical phase 3 evaluation of one or both therapies in development. With the acquisition of EB’s IP, Freya is currently seeking to attract new investors and strategic partners for the upcoming third phase of clinical trials in Europe.
About FSIAD
FSIAD is a type of sexual dysfunction and a recognized unmet medical need that lacks effective treatment. FSIAD is defined in the official DSM-5 Diagnostic and Statistical Manual of Mental Disorders, a publication by the American Psychiatric Association, as lack of, or significantly reduced, sexual interest and or arousal. As with other types of sexual dysfunction, FSIAD can be distressing. It can affect a person’s self-esteem, relationships, and overall well-being. A medical diagnosis requires a well-defined number of symptoms causing clinically significant distress that 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 Freya Pharma Solutions
Freya Pharma Solutions is an Amsterdam, the Netherlands, based pharmaceutical late clinical stage biotech company focusing on the development of effective pharmaceutical therapies for female sexual interest/arousal disorder (FSIAD). Freya will build further upon the previous fifteen years of research with two pharmaceutical compounds Lybrido and Lybridos, bringing a therapy for this recognized unmet medical need to the market and available to patients that suffer and experience great distress from this mental disorder.
Please contact for further information:
Freya Pharma Solutions
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
E: lmelens@lifespring.nl
