Testosterone/Sildenafil

AMSTERDAM, Feb. 22, 2023 /PRNewswire/ -- Freya Pharma Solutions, a late clinical stage company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Dysfunction (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 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 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, Lybrido™ and Lybridos™, 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. For further information please contact: Freya Pharma Solutions, Amsterdam Marcel Wijma, Chief Executive Officer [email protected] For media LifeSpring Life Sciences Communication, Amsterdam Leon Melens T: +31 6 538 16 427 E: [email protected] Logo: SOURCE Freya Pharma Solutions

Dr. Irwin Goldstein, Sue Goldstein, Prof. Sheryl Kingsberg, and Dr. Rachel Rubin AMSTERDAM, Feb. 10, 2023 /PRNewswire/ -- 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 Lybrido™ 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 Lybrido™ overseeing that the quality of research at Freya is maintained, as well as assessing its upcoming confirmatory clinical trials with Lybrido™. 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 Lybrido™, 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 Lybrido™ 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 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 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, Lybrido™ and Lybridos™, 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 [email protected] For media LifeSpring Life Sciences Communication, Amsterdam Leon Melens T: +31 6 538 16 427 E: [email protected] Logo: SOURCE Freya Pharma Solutions