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news.The US Food and Drug Administration (FDA) has approved Bionovo's total clinical development plan for Menerba, the company's drug candidate for menopausal hot flashes.
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Bionovo said that Menerba is an oral botanical drug candidate designed for the safe, effective treatment of vasomotor symptoms (hot flashes) associated with menopause.
Bionovo president and chief medical officer Mary Tagliaferri said that they had a very positive meeting with the FDA on their 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," Tagliaferri said.
"While we are awaiting 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."
Bionovo chairman and CEO Isaac Cohen said that 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.
"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," Cohen said.
"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."