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

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May 09, 2023, 05:17 ET

AMSTERDAM, May 9, 2023 /PRNewswire/ -- 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 Lybrido^™ 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 Lybrido^™ 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 Lybrido^™ 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 Lybrido^™ 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 Lybrido™ in the US marks a major next step in our plans to bring Lybrido^™ 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 Lybrido^™ 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 Lybrido^™ 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 (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 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™ and Lybridos™, 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.

www.freyapharmasolutions.com

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]

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SOURCE Freya Pharma Solutions