BIonovo reports strong Ph II data on Menerba

US drug developer Bionovo says that strong data on its drug to treat the  symptoms of the menopause were published in the March issue of the  journal Menopause. According to the firm, the findings showed that  Menerba (formerly MF101) is well tolerated, safe and effective for the  treatment of vasomotor symptoms (hot flashes and night sweats)  associated with the condition.

The Phase II trial was designed to evaluate the safety and efficacy of  two doses of Menerba versus placebo, and was conducted under the  direction of Deborah Grady, an international key opinion leader, from  the University of California, San Francisco. The evaluation was a  randomized, double-blinded, placebo-controlled study that enrolled 217  healthy post-menopausal women reporting severe hot flashes, and was  conducted at six clinical sites in the USA.

After 12 weeks of treatment, there was a statistically-significant  decrease in frequency of all hot flashes in the higher dose of Menerba  (p=0.04). There was also a very clear dose response trend in multiple  efficacy analyses. When compared to placebo, women in the Menerba  high-dose group were 2.3 times more likely to have at least a 50%  reduction in hot flashes after 12 weeks of treatment (p=0.03).