NDA Filed By Antares Pharma, Inc. Licensee For Transdermal Estradiol Gel (Bio-E-Gel(TM))
Antares Pharma, Inc. (Amex:AIS) announced today that its licensee BioSante Pharmaceuticals, Inc. (Amex:BPA),has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Bio-E-Gel(TM) (a product based on Antares' proprietary ATD(TM) 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. The NDA is seeking approval for all three doses. Results of the Phase III study also reported that beginning in Week 5, the low dose showed a highly significant decrease in the number of and severity of hot flashes versus placebo, therefore suggesting identification of the lowest effective dose. This significant response was also maintained through Week 12. Importantly, over 80 percent of women who used Bio-E-Gel(TM) reported "moderate" or "great" results. 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.