Freya Pharma Solutions, a pharmaceutical company dedicated to developing effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders announced today that the United States (US) Food and Drug Administration (FDA) has responded with interest and provided valuable input regarding Freya Pharma’s request for advice on the US Clinical Development Program of LybridoTM for the treatment of Female Sexual Interest/Arousal Disorder (FSIAD).

After receiving guidance from the European Medicines Agency (EMA) in September 2022, Freya Pharma Solutions is currently preparing for the ALETTA confirmatory clinical trial as part of the clinical development program of LybridoTM in Europe. The ALETTA trial is scheduled to commence in early 2024. In parallel, Freya Pharma has collaborated closely with its Scientific Advisory Board, which comprises renowned experts in the field of Female Sexual Disorders (FSD) from both the US and Europe, to design a clinical development program for the United States. The aim is to support a future Marketing Authorization Application (MAA) for LybridoTM in the US. In response to Freya Pharma’s request for advice, the FDA has shown keen interest and provided valuable guidance for the company’s clinical development program of LybridoTM.

Dr. Jan van der Mooren, Chief Medical Officer at Freya Pharma Solutions said:

“The response from the FDA regarding Freya Pharma’s clinical development program for LybridoTM in the US fills me with optimism, as it suggests we are moving in the right direction to bring LybridoTM to the market, and make a meaningful impact on the lives of numerous women affected by FSD. The FDA conducted a thorough review of our program, and provided clear answers to our questions. Additionally, the Agency offered invaluable advice on study designs, which we will gratefully incorporate into our program. I am confident that these inputs will enhance the quality of our clinical trials, and improve the likelihood of a successful outcome, which is essential before launching LybridoTM in the market. It is evident that there is a significant unmet need among women grappling with FSD for effective and safe treatments, currently lacking in Europe and very limited in the US. LybridoTM is expected to address this pressing need. Freya Pharma is highly assured that we are well on track with the clinical development of LybridoTM as a treatment for women experiencing sexual disorders and the associated distress that often adversely impacts their quality of life and relationships.”

 

Source:freyapharmasolutions.com

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