Freya Pharma Solutions Announces Advice from the FDA on its US Clinical Development Program of LybridoTM for the treatment of Female Sexual Interest/Arousal Disorder

 

Freya Pharma Solutions, a pharmaceutical company focusing on the development of effective pharmaceutical therapies for women diagnosed with Female Sexual Disorders (FSD), announced today that the United States (US) Food and Drug Administration (FDA) has informed Freya that they will provide a written response by 4 June on the request for advice on the US Clinical Development Program of Lybrido^TM for the treatment of Female Sexual Interest/Arousal Disorder (FSIAD).

After obtaining advice from the European Medicines Agency (EMA) in September 2022, Freya Pharma Solutions is currently preparing the confirmatory ALETTA trial as part of the clinical development program of Lybrido^TM in Europe. As a next step Freya has designed a clinical development program for the US in close collaboration with its Scientific Advisory Board consisting of leading experts in the field of FSD from the US and Europe, to prepare for a Marketing Authorization Application (MAA) of Lybrido^TM in the US. On Freya’s request for advice, the FDA has now planned to provide a written response by 4 June 2023, where Freya’s objective is to reach an agreement with the agency regarding the clinical development program of Lybrido^TM in the US.

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

"The announced response from the FDA on our clinical development program for Lybrido^TM in the US marks a major next step in our plans to bring Lybrido^TM to the market, and to make a contribution to the lives of many women suffering from FSD.  It can be concluded that there is a high unmet need among women suffering from FSD for effective and safe treatments, which are currently not available in Europe and are very limited in the US, and that Lybrido^TM is expected to address such a need. The ALETTA confirmatory clinical trial is planned to start soon in Europe, and we hope that with the advice from the FDA we can also soon start preparing clinical trials in the US. The company is highly confident that it is well on track with the clinical development of Lybrido^TM as a treatment for women suffering from sexual disorders and the related distress which often negatively interferes with their quality of life and their relationships.”