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news.Bionovo has released positive results from an open-label, randomized trial evaluating Menerba (MF101) as a treatment for menopausal hot flashes.
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The primary goal of the study was to evaluate the safety and tolerability of two doses of Menerba, higher than those previously tested during the Phase 2 studies, after 4 weeks of treatment.
The primary endpoint of the study was to test the safety of two higher doses of Menerba.
The results of the trial showed that Menerba is a safe therapy for the treatment of menopausal hot flashes.
The company has established a definitive dosing strategy for the Phase 3 clinical trial.
Bionovo president and chief medical officer Isaac Cohen said as predicted by the dose response seen in their Phase 2 trial, higher doses of Menerba tested in our Phase 1 study demonstrated higher efficacy.
"After 4 weeks on therapy, the reduction in moderate to severe hot flashes was approximately 70% with a p value of 0.003 for women who took a dose of Menerba that has twice the potency than the highest dose tested in our Phase 2 study," Cohen said.
"In addition, there was a 68% reduction in the number of nighttime awakenings due to hot flashes with a p value of 0.001."