BIOSANTE PRESENTS RESULTS OF MENOPAUSE DRUG STUDY

Antares Pharma has announced that its North American licensee, BioSante, has presented a full report of the results of its Phase III clinical study data on Bio-E-Gel (bio-identical estradiol gel) at the North American Menopause Society annual meeting in San Diego, Calif. The study results showed three doses of Bio-E-Gel that significantly decrease the number of hot flashes in menopausal women and identified the lowest effective dose in order to implement estrogen therapy.

The Phase III trial was a 12-week, randomized, double-blind, placebo-controlled study of 484 symptomatic menopausal women using three dosage levels of Bio-E-Gel in order to establish its safety and efficacy for the treatment of hot flashes, which are known to occur in up to 85 percent of menopausal women. Results showed that the most effective dose decreased the number of hot flashes by 88 percent from 12.9 per day at baseline to 1.6 after treatment. The decrease was also significant versus placebo, with a mean decrease of 11.3 hot flashes per day with Bio-E-Gel versus a decrease of 6.1 with placebo. Bio-E-Gel also produced low estradiol blood levels and had a safety profile similar to that observed in the placebo group. There was minimal application site irritation reported, a side effect known to be associated with transdermal patches.