BIOSANTE ANNOUNCES FDA REVIEW OF NDA FOR BIO-E-GEL

BioSante Pharmaceuticals has announced today that its new drug application (NDA) for Bio-E-Gel (transdermal estradiol gel), an innovative low-dose topical therapy for moderate-to-severe hot flashes in menopausal women, has been accepted for filing and review by the FDA. Bio-E-Gel is a gel formulation of estradiol, the same estrogen produced naturally in women, developed to be quickly absorbed through the skin after topical application on the upper arm , delivering estradiol to the bloodstream evenly over time at minimal dosage and in a fast drying, non-invasive, painless manner.

A 12-week, double-blind, placebo-controlled Phase III study of 484 symptomatic menopausal women was designed to identify the lowest effective dose in order to implement estrogen therapy in the safest possible manner. The women in the study were randomly assigned to one of four treatment arms: low-dose, mid-dose or high-dose Bio-E-Gel, or matching placebo.