AMSTERDAM, Aug. 25, 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 filing of new patent applications for improved treatment of FSIAD.
Last year Freya, Pharma Solutions acquired all Intellectual Property (IP) on 2 innovative drugs, Lybrido and Lybridos, developed for the treatment of women suffering from FSIAD. With the new patent applications announced today, Freya will significantly strengthen its IP position in this area, and add strong additional protection up until 2042, thereby extending its value life cycle.
Upcoming pivotal phase 3 trial
Freya Pharma Solutions plans to conduct a pivotal phase 3 clinical trial to confirm the efficacy and safety of Lybrido in women suffering from FSIAD. In June this year a clinical trial application was submitted to the European Medicines Agency (EMA) for scientific advice on the upcoming pivotal phase 3 clinical trial with Lybrido for the treatment of FSIAD. 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.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:
“Lybrido is a unique therapeutic concept, both by its combination of testosterone and sildenafil, as well as by its dual route, dual release, fixed dose system, and as such achieving the optimal synergy of both active ingredients. 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 the new patent applications Freya will further strengthen its IP position and provide strong protection for effective and safe treatment for women suffering from 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.
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
E: [email protected]
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SOURCE Freya Pharma Solutions