BioSante Pharmaceuticals files NDA for Bio-E-Gel

By Elaine Rigoli

Tampa, Fla., April 19 - BioSante Pharmaceuticals, Inc. announced Wednesday that its New Drug Application for Bio-E-Gel (transdermal estradiol gel), a low-dose topical therapy for moderate-to-severe hot flashes in menopausal women, has been accepted for filing and review by the Food and Drug Administration.

Bio-E-Gel is a gel formulation of estradiol, developed to be absorbed through the skin after topical application on the upper arm, delivering estradiol to the bloodstream evenly over time at minimal dosage, according to a news release.

A 12-week, double-blind, placebo-controlled phase 3 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 a matching placebo.

The four co-primary endpoints, as defined by the FDA, were a significant decrease over the placebo in both the number and severity of hot flashes at week four and week 12 of treatment.

There was a clear dose response in the reduction in the number and severity of hot flashes across the low, mid, and high doses tested in the phase 3 trial, the release said.

Also, the company said more than 80% of women who used Bio-E-Gel reported "moderate" or "great" results.

The company is seeking approval for all three doses.

Located in Lincolnshire, Ill., BioSante develops hormone-therapy products to treat both men and women.

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