BioSante Pharmaceuticals, Inc. has announced significant Phase III safety and efficacy results of Bio-E-Gel (bioidentical estradiol transdermal gel) for the treatment of moderate-to- severe hot flashes in menopausal women. A new drug application (NDA) will 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, are a significant decrease over placebo in both the number and severity of hot flashes at Week 4 and Week 12 of treatment.
"We are very pleased the Phase III trial results indicate the lowest effective dose of Bio-E-Gel thereby establishing the safest dose for women to begin treatment for reducing hot flashes. We look forward to completing the preparation and submission of the NDA as soon as possible," Dr. Leah M. Lehman, vice president of product development of BioSante said.
Stephen M. Simes, president and CEO of BioSante asserts, "We believe Bio-E-Gel will be well positioned to compete in the US estrogen therapy market, currently estimated to total approximately $1.4 billion in annual sales."