New drug for menopausal hot flashes gets FDA approval for development plan

Menerba, a new drug to cure menopausal hot flashes by pharmaceutical company Bionovo, Inc has got the US Food and Drug Administration approval stamp on Thursday for company's total clinical development plan for Menerba. The company focuses on discovery and development of women's health and cancer drugs.

“We had a very positive meeting with the FDA on our clinical program for Menerba. As anticipated, they agreed with our overall clinical development plan which included the number of clinical trials, number of subjects and length of exposure as well as non-clinical studies necessary for New Drug Application (NDA) submission for a non-estrogen drug such as Menerba. They also provided useful suggestions for improving the clinical trial protocols” Mary Tagliaferri, M.D., Bionovo’s President and Chief Medical Officer said.

"While we are waiting the formal minutes from the FDA meeting, we are moving forward to implement the agency's suggestions and have forwarded the approved clinical trial design to our investigators and their investigational review boards, or IRBs," she added.

"Menerba is a first-in-class, unique drug candidate that is intended for a large medical need, for the safe and effective treatment of menopausal symptoms,” said Isaac Cohen, Bionovo's Chairman and Chief Executive Officer.

"We want to do everything necessary to bring Menerba to market for the treatment of hot flashes, while we also investigate its potential use in the treatment of breast cancer prevention. Now that we have agreements with the FDA and the EMA (the European Medicines Agency) on the overall development of Menerba, we have accelerated discussions with potential partners to successfully bringing Menerba to market," he said.

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