Positive phase II/III trial results reported for estradiol topical gel.

2003 JUN 5 - (NewsRx.com & NewsRx.net) -- BioSante Pharmaceuticals, Inc., (BISP) announced that an effective dose of Bio-E-Gel (estradiol topical gel) has been identified in its phase II/III clinical trial for the treatment of moderate-to-severe hot flushes in menopausal women.

The phase II/III trial, conducted in the United States and Canada, was a randomized, double-blind, placebo-controlled study of 161 symptomatic menopausal women. This trial follows two dose-ranging phase II clinical trials, which demonstrated that Bio-E-Gel, applied as a topical gel, successfully delivers therapeutic doses of estradiol.

The objective of the phase II/III clinical trial was to identify an effective dose of Bio-E-Gel to study in phase III development. The phase II/III trial demonstrated that Bio-E-Gel effectively reduces the severity and frequency of moderate-to-severe hot flushes in menopausal women, according to Food and Drug Administration (FDA) guidances for development of estrogen products.

Additionally, Bio-E-Gel delivers estradiol evenly over time without significant fluctuations in blood levels, such as those typically associated with hormone tablets. Furthermore, even though Bio-E-Gel was applied daily to the same site, minimal skin irritation, typically associated with patches, was observed. Of the 161 women in the trial, only 4 women experienced a brief episode of mild skin irritation.

Current FDA requirements for approval of new estradiol products include one 12-week phase III clinical trial. The clinical endpoints of the required phase III trial include a significant reduction in the severity and frequency of hot flushes at week 4 and week 12 of treatment as compared to placebo. The effective dose of Bio-E-Gel will be used in the pivotal phase III trial required for approval of Bio-E-Gel. This phase III clinical trial of Bio-E- Gel is scheduled to begin this year.

"With an effective dose of Bio-E-Gel now identified, we are extremely eager to move into phase III development as soon as possible," said Stephen M. Simes, president and chief executive officer of BioSante. "This is a very important milestone for BioSante. We have been committed to moving our pipeline of hormone therapy products through clinical trials ...