Antares Pharma Inc. announced that its licensee, BioSante Pharmaceuticals Inc., has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for Bio-E-Gel, a product based on Antares' proprietary ATD gel technology, to treat moderate-to-severe hot flashes in menopausal women. Across the low, mid and high doses tested in the Phase III trial, it was reported that there was a clear dose response in the reduction in the number and severity of hot flashes.
Importantly, over 80 percent of women who used the product reported "moderate" or "great" results, reported the companies. It was also reported that there were no significant differences in the safety profile of any doses when compared to placebo other than for predictable estrogen effects such as breast tenderness. The Bio-E-Gel incorporates Antares Pharma's proprietary advanced transdermal delivery (ATD) gel system, which is designed to allow delivery of hormones and other active ingredients across the skin. This system reportedly allows active ingredients to be absorbed quickly following application. The current U.S. market for estrogen products is estimated at approximately US$1.4 billion in annual sales and the European market is estimated to be equally substantial.