Freya Pharma Solutions: ALETTA Pivotal Trial Well Received at ISSM/SMSNA Scientific Meeting
Freya Pharma Solutions, a late clinical stage pharmaceutical company focusing on the development of effective pharmaceutical therapies for women diagnosed…
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), has presented the design of its upcoming ALETTA pivotal clinical trial with Lybrido™ at the 23rd ISSM/SMSNA Scientific Meeting. The International Society for Sexual Medicine (ISSM) Scientific Meeting & 23rd Annual Fall Scientific Meeting of Sexual Medicine Society of North America (SMSNA), was held late October 2022 in Miami Beach, Florida. The paper titled ‘Design of the ALETTA Clinical Study: A Randomized Double-Blind Placebo-Controlled Study investigating the Efficacy and Safety of Lybrido™ in Premenopausal Women with Acquired FSIAD‘, was presented by first author Dr. Cobi Reisman and got a warm scientific reception by attending health professionals from all over the world.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:
“Presenting our ALETTA trial at this conference is an important step in acquiring feedback from an audience of international professionals in sexual medicine on our clinical development plans. The abundance of positive comments confirms our belief that there is a great unmet need for an effective treatment of female sexual problems, and that Lybrido™ has the potential to fill in that gap. The concept of Lybrido™, creating a unique synergy of testosterone and sildenafil, is recognized by international experts as an innovative drug on a market with only two approved drugs for FSIAD in the United States, while no drug being approved in Europe so far.”
Freya Pharma Solutions is currently preparing the clinical development program with several studies in Europe, to be followed later by additional trials in the United States. 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 dysfunction, and the related distress which often negatively interferes with their quality of life and their relationships.
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 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 safety and efficacy of two novel on-demand pharmacological treatments. Lybrido™ increases central sexual motivation and physiological sexual responses, such as swelling of genital erectile tissue and vaginal lubrication. The therapy is being developed as ‘on demand’ treatment with the aim to increase central sexual motivation from 3 to 6 hours after intake. This treatment comprises 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, Chief Executive Officer
E: [email protected]
LifeSpring Life Sciences Communication, Amsterdam
T: +31 6 538 16 427
E: [email protected]