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Home » BIOSANTE ANNOUNCES PHASE III DATA FOR BIO-E-GEL
BIOSANTE ANNOUNCES PHASE III DATA FOR BIO-E-GEL
July 8, 2005
BioSante recently unveiled Phase III safety and efficacy results for its Bio-E-Gel (bioidentical estradiol transdermal gel) for the treatment of moderate-to-severe hot flashes in menopausal women. The company said a new drug application would be filed as soon as possible after completion of the data analyses.
The Phase III trial was a 12-week, randomized, double-blind, placebo-controlled study of 484 symptomatic menopausal women. Following FDA recommendations, the Phase III trial tested three doses of Bio-E-Gel in order to establish the lowest effective dose and maximize the safety profile. The four co-primary endpoints, as defined by the FDA, were a significant decrease over placebo in both the number and severity of hot flashes at Week 4 and Week 12 of treatment.
Across the low, mid, and high Bio-E-Gel doses tested in the Phase III trial, there was a clear dose response in the reduction in the number and severity of hot flashes, the company said. There were no significant differences in the safety profile of any dose of Bio-E-Gel compared to placebo.
A full report of the Phase III trial data is targeted for a medical meeting in the fall with publication in a peer-reviewed journal to follow, BioSante said.
KEYWORDS Drug Pipeline Alert
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