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, June 29, 2022 /PRNewswire/ -- 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.
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.
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
LifeSpring Life Sciences Communication, Amsterdam
T: +31 6 538 16 427
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