Antares Pharma's Licensee Announces First Transdermal Estradiol Gel With Three Doses That Significantly Decrease Hot Flashes in
September 30 2005 - 7:00AM
PR Newswire (US)
88% Decrease in Hot Flashes and the Lowest Effective Dose is
Established, According to the Results Reported EXTON, Pa., Sept. 30
/PRNewswire-FirstCall/ -- Antares Pharma, Inc. (AMEX:AIS) announced
today that its North American licensee, BioSante Pharmaceuticals,
Inc. (AMEX:BPA) has presented a full report of the results of its
Phase III clinical study data on Bio-E-Gel(TM) (bio-identical
estradiol gel) at the North American Menopause Society (NAMS)
annual meeting in San Diego, CA. The study results showed three
doses of Bio-E-Gel(TM) 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(TM) in order to establish safety and efficacy of
Bio-E-Gel(TM) for the treatment of hot flashes, which are known to
occur in up to 85% of menopausal women. Results showed that the
most effective dose decreased the number of hot flashes by 88% from
12.9 per day at baseline to 1.6 after treatment (p
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