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 submission of the trial protocol application with the European Medicines Agency (EMA) for scientific advice on the upcoming pivotal phase 3 clinical study with Lybrido for the treatment of FSIAD. Freya expects to receive the EMA scientific advice no later than October 2022. The phase 3 trial will start in late 2022/early 2023, with interim results expected by the second half of 2023.
Dr. Jan van der Mooren, Chief Medical Officer of Freya, stated:
“This application for EMA scientific advice is a major step in Freya’s development program for Lybrido, which is offering an effective and safe treatment for women suffering from FSIAD. 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 great support of the members of the Scientific Advisory Board, Freya has drafted a thorough and detailed clinical study protocol of a randomized placebo-controlled phase 3 clinical trial to demonstrate the efficacy and safety of Lybrido. Clinical research organization CR2O BV (www.CR2O.nl) is leading the preparation, execution and reporting of this trial.
The trial has been given the short name “ALETTA", referring to Aletta Henriëtte Jacobs, a Dutch physician and women's suffrage activist. As the first woman to officially attend a Dutch university, she became one of the first female physicians in the Netherlands.
Freya Pharma Solutions is currently preparing the first phase 3 clinical trial in Europe as part of a clinical development program with several studies in Europe, and later also in the United States. The company is highly confident that it is well on track with establishing Lybrido as a treatment for women suffering from sexual dysfunction, and the related distress which often negatively interferes with their quality of life.