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news.BioSante Pharmaceuticals' new drug application for Bio-E-Gel, a low-dose topical therapy for moderate-to-severe hot flashes in menopausal women, has been accepted for filing and review by the FDA.
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Bio-E-Gel is a gel formulation of estradiol, the same estrogen produced naturally in women, developed to be quickly absorbed through the skin after topical application on the upper arm, delivering estradiol to the bloodstream evenly over time at minimal dosage.
“This bio-identical estrogen gel formulation may not only offer greater comfort and convenience over a pill or a patch, but we believe the lowest effective dose was identified in clinical trials at unusually low daily delivery of estrogen,” said Stephen Simes, president and CEO of BioSante. “Thus, if and when approved, Bio-E-Gel may become the lowest dose of estrogen available to treat hot flashes, making it an attractive alternative to currently marketed estrogen therapies.”
The new drug application is partly based on a 12-week, double-blind, placebo-controlled phase III study of 484 symptomatic menopausal women was designed to identify the lowest effective dose in order to implement estrogen therapy in the safest possible manner.