Freya Pharma Solutions Announced Further Strengthening of its IP Position for Improved Treatment for Women Suffering From FSIAD

Freya Pharma Solutions Announced Further Strengthening of its IP Position for Improved Treatment for Women Suffering From FSIAD

Amsterdam, the Netherlands, 25 August 2022 - 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.”