Emotional Brain is interested in the regulatory mechanisms of emotions in the brain. Ever since the company was founded, we have pursued the development of intelligent medical systems, or personalized medicine. Our particular commitment and focus concern the condition known as Female Sexual Interest/Arousal Disorder (FSIAD).
To help women who suffer from this condition, we have performed several clinical studies to investigate the efficacy of two specific medication combinations, Lybrido and Lybridos, on sexual function in women diagnosed with FSIAD.
In the Netherlands, we have successfully completed Phase 1 and Phase 2 clinical studies into the safety and efficacy of these two drugs, Lybrido and Lybridos. The results of the Dutch Phase 1 and Phase 2A studies were very promising, and in collaboration with the US Food and Drug Administration (FDA) we entered Phase 2B in the US. The Phase 2B studies were conducted at 17 research sites in the United States. Currently, we are preparing Phase 3 trials, again in close collaboration with the FDA and European Medicines Agency (EMA). Phase 3 is the final phase before new drug applications can be submitted to the regulatory authorities (e.g. FDA and EMA).
Our products are protected by a strong patent portfolio, consisting of various families, including the formula of the chemical composition, method of administration, and product-specific patents.
Based on the highly promising results so far, we feel confident that FDA and EMA approval to market the new drugs will be granted in the near future, so that we can launch effective treatment options for FSIAD that address the specific needs of individual patients.