BioSante's Bio-E-Gel reduces hot flashes at lowest dose during phase 3 study

By Lisa Kerner

Erie, Pa., March 10 - BioSante Pharmaceuticals, Inc. said its Bio-E-Gel reduced the number of hot flashes in up to 52% of the 484 symptomatic menopausal women enrolled in a 12-week, randomized, double-blind, placebo-controlled phase 3 study.

Depending on the dose, between 25% and 52% of women in the trial had 100% reduction of hot flashes by the end of the study, a statistically significant reduction compared to a placebo, according to a company news release.

Bio-E-Gel, a gel formulation of estradiol, is designed to be absorbed through the skin after topical application on the arm and shoulder.

The phase 3 study tested three doses of Bio-E-Gel to determine the lowest effective dose and maximize the safety profile, according to the release.

BioSante said the four co-primary endpoints of the study were a significant decrease over a placebo in the number and the severity of hot flashes at weeks 4 and 12 of treatment.

Across the low, mid, and high Bio-E-Gel doses, there was a clear dose response in the reduction of the number and severity of hot flashes. While the lowest dose showed a significant decrease in the number and severity of hot flashes compared to a placebo at week 5, BioSante said it is seeking Food and Drug Administration approval for all three doses.

There were no significant differences in the safety profile of any dose compared to a placebo other than for estrogen effects such as breast tenderness, the company said.

"We believe Bio-E-Gel, if and when approved by the FDA, will be well positioned to compete in the U.S. estrogen therapy market, currently estimated to total approximately $1.3 billion in annual sales," president and chief executive officer Stephen M. Simes said in the release.

BioSante presented data from the study at the International Society for the Study of Women's Sexual Health in Lisbon, Portugal.

BioSante is developing a pipeline of hormone therapy products to treat both men and women. The company is based in Lincolnshire, Ill.

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