BIOSANTE ANNOUNCES BIO-E-GEL NDA SUBMISSION

BioSante Pharmaceuticals has submitted a new drug application (NDA) to the FDA for Bio-E-Gel (transdermal estradiol gel) to treat moderate-to-severe hot flashes in menopausal women.

The NDA includes data from one pivotal Phase III clinical trial of Bio-E-Gel and data from three additional clinical trials required by the FDA, including a transfer study, a sunscreen study and a pharmacokinetic study.

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.