Freya Pharma Solutions Announces Response from the FDA on its US Clinical Development Program of LybridoTM for the treatment of Female Sexual Interest/Arousal Disorder

AMSTERDAM, June 19, 2023 /PRNewswire/ -- 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 Lybrido^TM 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 Lybrido^TM 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 Lybrido^TM 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 Lybrido^TM.

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 Lybrido^TM in the US fills me with optimism, as it suggests we are moving in the right direction to bring Lybrido^TM 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 Lybrido^TM 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. Lybrido^TM is expected to address this pressing need. Freya Pharma is highly assured that we are well on track with the clinical development of Lybrido^TM 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 (Lybrido^TM) and women with dysfunctional over-activation of sexual inhibition (Lybridos^TM). Lybrido^TM 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, Lybrido^TM and Lybridos^TM, 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
[email protected]

For media 
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
E: lmelens@lifespring.nl

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SOURCE Freya Pharma Solutions