Freya Pharma Solutions has launched a Phase II clinical study evaluating its investigational therapy Lybrido for Female Sexual Interest/Arousal Disorder (FSIAD), employing an innovative ultrasound technique to objectively measure treatment efficacy. The Amsterdam-based pharmaceutical company announced the study will investigate two dose-combinations of testosterone and sildenafil, marking a significant step forward in addressing an underserved medical need affecting women worldwide.
Novel Measurement Approach for Sexual Dysfunction
The investigator-initiated study, led by Principal Investigator Prof. Cobi Reisman and Co-Investigator Dr. Anna Padoa at the Chaim Sheba Medical Center, will assess objective physiological measurements of arousal response in premenopausal women diagnosed with acquired generalized FSIAD. The research employs Clitoral Doppler Duplex Ultrasound imaging to quantify clitoral blood flow parameters, which serve as a key biomarker of genital arousal.
"Combination therapy of sublingual testosterone and oral sildenafil is reported as a potentially effective and safe treatment option for premenopausal women with FSIAD," said Prof. Cobi Reisman, MD, PhD, FCESM, ECPS. "Sexual function is frequently measured with validated and standardized questionnaires to determine the subjective sexual response, whereas objective measures warrant physical measurement. In this regard, clitoral vascularization is reported as a relevant physiological indicator of the female genital arousal response."
Lybrido's Dual-Action Mechanism
Lybrido represents a novel dual-route, dual-release, fixed-dose combination tablet featuring a testosterone coating for sublingual administration and an inner-core component containing sildenafil, a phosphodiesterase type 5 (PDE 5) inhibitor. The inner-core component is coated with a delayed-immediate-release matrix designed 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.
The therapy can be taken on-demand and helps increase central sexual motivation from 3 to 6 hours after intake. According to the company, Lybrido increases central sexual motivation and physiological sexual responses, such as swelling of genitals and lubrication, enabling an increase in genital arousal through increased responsivity to sexual stimuli.
Extensive Clinical Development Program
Lybrido has undergone substantial clinical testing, with a total of 20 Phase I and Phase IIa trials, plus large-scale Phase IIb trials conducted across 17 research sites in the United States. These trials have investigated the efficacy and safety of two novel on-demand pharmacological treatments designed to treat FSIAD: Lybrido and Lybridos.
Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions, noted that "the combination of sublingual testosterone and oral sildenafil being studied by Prof. Reisman and Dr. Padoa closely mirrors the mechanism of action of Lybrido, our investigational product for women diagnosed with FSIAD."
Pivotal European Study on the Horizon
Concurrently with the Phase II study, Freya Pharma Solutions is finalizing preparations for the ALETTA clinical study, a pivotal trial as part of Lybrido's European clinical development program. Enrollment is scheduled to begin in late 2025 across 20 European research sites in five countries.
Addressing Significant Unmet Medical Need
Female Sexual Interest/Arousal Disorder represents a significant health concern, with low sexual desire consistently reported as the most common issue affecting women. This widespread challenge often leads to clinically significant distress, dissatisfaction in intimate relationships, and profoundly impacts emotional well-being and social connections.
According to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), FSIAD combines persistent reductions in both sexual interest and/or arousal, requiring symptoms to persist for six months while causing clinically significant distress. Clinicians diagnose FSIAD through specific symptom thresholds and categorize it by severity and subtype. FSIAD represents the clustering of Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder, listed in the World Health Organization's International Classification of Diseases, 11th Revision (ICD-11).
Freya Pharma Solutions, which has built upon fifteen years of research in this field, aims to offer patients a convenient, personalized on-demand solution for this recognized unmet medical need. The company's focus on developing effective pharmaceutical therapies for FSIAD represents a significant advancement in women's sexual health treatment options.
