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EMA Scientific Advice for Lybrido and Lybridos Endorses Company Proposals

ALMERE, The Netherlands, February 4, 2014 /PRNewswire/ --

On January 29th, 2014, Emotional Brain received the Scientific Advice letters from the European Medicines Agency (EMA) for the products Lybrido and Lybridos. The company is very pleased to announce that virtually all company proposals on the development plans for the two products were endorsed.

Emotional Brain has adopted a 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.

Following a very fruitful oral discussion meeting between the experts from Emotional Brain and the EMA's Scientific Advice Working Party (SAWP), held in London on 9 January 2014, the final scientific advice for Lybrido and Lybridos as agreed upon by the SAWP was adopted by the EMA's Committee for Human Medicinal Products (CHMP) in their meeting on 20-23 January 2014.

The main message which can be taken from the two scientific advice letters is that Emotional Brain has the green light to start with its proposed Phase III clinical study program, and that Emotional Brain's proposed overall development program is considered sufficient for a future Marketing Authorisation Application, without the need to perform any nonclinical pharmacology or toxicology studies, additional dose-finding studies, or further comparative studies versus the individual components of the Lybrido or Lybridos fixed dose combination tablets.

Moreover, the EMA is endorsing Emotional Brain's proposals on the overall Phase III clinical study programme and the design features of the individual Phase III clinical studies (including study endpoints) as being acceptable for a future marketing authorisation application (i.e. for registration). This includes the company's proposal for the further refinement of the diagnostic methodology to classify patients into the two subsets to be treated with either Lybrido or Lybridos.

Where the EMA agrees with the majority of the company's proposals on the design of the Phase III clinical studies, some additional valuable advice is given for minor modifications of the proposed efficacy and safety parameters, and statistical methodology. Moreover, in order to achieve a proper assessment of the long-term safety profile in women, next to the already scheduled assessments during Phase III, the EMA recommends to plan for adequate post-registration measures (to be taken into account once the products are on the market) as part of a Risk Management Plan to be submitted as part of the future registration file.

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