Executive Summary

BioSante plans an NDA submission for its transdermal estradiol gel Bio-E-Gel "as soon as possible" following positive results from a Phase III trial in menopausal women. The 12-week, 484-patient study looked at three dose levels. Beginning at week five, highly significant decreases in the number (p<0.001) and severity (p<0.01) of hot flashes compared to placebo were observed with the lowest study dose. "We believe the low dose…will be an attractive alternative to currently marketed estrogen therapies," BioSante says. The company is aiming at the market created largely by Solvay's EstroGel. BioSante also hopes to tap into the female sexual dysfunction market with its testosterone gel LibiGel. A Phase III study in FSD is slated to begin by year-end (1Pharmaceutical Approvals Monthly April 2005, p. 5)...