Emotional Brain's Development of Lybrido and Lybridos Discussed with the FDA
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ALMERE, The Netherlands, December 17, 2013
Emotional Brain is a scientific research company engaged in the development (and implementation) of intelligent reasoning programs and medications directed at a personalized approach to healthcare. The foundation for this work is the premise that there exist individual differences in the causes of certain diseases. When different causal mechanisms can be elucidated for a physical or mental illness, more focused medical or psychological treatments are possible.
Emotional Brain has adopted this personalized approach to medicine in the development of two drugs for the treatment of Female Sexual Dysfunction (FSD): Lybrido and Lybridos. Lybrido is designed for women with FSD (with low sexual desire/arousal) due to a relatively insensitive brain system for sexual signals. Lybridos is designed for a different group of women with FSD, those for whom an overactive sexual inhibition system in the brain is the cause of their condition. Both Lybrido and Lybridos are "on demand" drugs, to be taken only when desired.
To identify who might best be treated by each of these drugs, Emotional Brain has developed a demarcation formula based on biological and psychological variables. The demarcation formula is intended to be used in conjunction with the current criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM) to subtype the existing patient population with FSD.
Emotional Brain recently had positive and productive meetings with the FDA to discuss the results of the Phase 2 clinical studies of Lybrido and Lybridos and plans for the pivotal Phase 3 registration studies. (Emotional Brain is also currently engaged in similar communications with the European Medicines Agency.) A key topic of discussion with the FDA was the categorization of patients who are the focus of Emotional Brain's approach to personalized medicine for FSD. The FDA recommended that validated diagnostic tools be used to subtype patients for inclusion in the Phase 3 studies. Furthermore, the FDA stressed the need for a simple and practical tool that healthcare providers can use (postapproval) to make an accurate subtype assignment for optimal patient treatment.
In addition to obtaining FDA feedback on patient demarcation, preliminary agreement was reached on the outline of the Phase 3 study design, including the nature of the primary and secondary endpoints. Before the start of the pivotal trials, expected to begin in the fall of 2014, the proposed final study protocol for Lybrido will be submitted to the FDA for a Special Protocol Assessment (SPA). The FDA encouraged Emotional Brain to make use of the SPA procedure so that Emotional Brain can benefit from the Agency's expertise.
While the primary focus was on Lybrido, which is slightly further along in development, the interim results for Lybridos were also discussed with the FDA. The feedback from this constructive meeting will be incorporated in future studies of Lybridos. It was agreed that another meeting will be scheduled to discuss Lybridos when the Phase 2 research has been completed and positive results have been demonstrated.
"We are very well aware that we have a personal sexual medicine approach, which is different compared to the usual approach in the development of medications for FSD," said Adriaan Tuiten, the CEO of Emotional Brain. "We consider the constructive and positive attitude of the FDA an important milestone for the next stage in the development of our products and look forward to future discussions with the FDA."
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