ALMERE, the Netherlands, May 1, 2015 /CNW/ - The scientific research company Emotional Brain is developing two on-demand medicines (i.e. to be taken when desired) for Female Sexual Interest/Arousal Disorder (FSIAD), considered by many as an unmet medical need. Recently Emotional Brain had positive and productive meetings with the U.S. Food & Drug Administration (FDA) to discuss their Phase 3 clinical development program for Lybrido, which is planned to commence in Q3/Q4 2015. Emotional Brain discussed their Phase 3 program with the FDA under their Special Protocol Assessment (SPA) procedure. In these discussions, Emotional Brain's clinical program was strengthened and aligned with the FDA's expectations and recommendations. Emotional Brain expects to reach final agreement on the SPA shortly, and will start the Lybrido Phase 3 program within the next few months.
"After our highly successful interactions with the European Medicines Agency we are pleased with the in-depth discussions with the FDA and further streamlining of our clinical program. The continuing positive and constructive collaboration between our team and the FDA has really optimized our development program, and we are very much looking forward to start our Phase 3 program for which the preparations are well underway. With this timeline we should be able to reach the market in Q4 of 2017," said Adriaan Tuiten, the CEO of Emotional Brain. For the commercialization of both Lybrido and Lybridos, the Emotional Brain team is being professionally supported by Deloitte's LifeTrack Team.
Emotional Brain has adopted a true personalized sexual medicine approach in the development of different treatments of FSIAD. The foundation for this work is the premise that individual differences exist in the causes of sexual dysfunction. When different causal mechanisms are elucidated, more focused medical or psychological treatments are possible. Lybrido is designed for women with FSIAD due to a relatively insensitive brain system for sexual signals. Lybridos is designed for a different group of women with FSIAD, those for whom an overactive sexual inhibition system in the brain is the cause of their condition.
SOURCE Emotional Brain