Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.BioSante Pharmaceuticals has shown its estrogen based gel can significantly reduces hot flashes in menopausal women, causing the company's stock to jump by over 5%.
Subscribe to our email newsletter
The results of a phase III safety and efficacy study of Bio-E-Gel (bioidentical estradiol transdermal gel) for the treatment of moderate-to-severe hot flashes in menopausal women indicate the product to be both safe and effective.
The company said it would file a new drug application as soon as possible after completion of the data analyses.
The treatment has been licensed to BioSante from the drug development company Antares Pharma. BioSante retains rights to the drug in the US and certain other territories, while Antares can utilize and reference the data obtained from clinical trials in order to develop its own estradiol gel products for release in Europe, Japan and other markets.
Antares said it expects to receive contractually agreed milestone payments at certain stages of development and royalties on end sales in the US upon commercialization.
The trial of 484 symptomatic menopausal women tested three doses of Bio-E-Gel in order to establish the lowest effective dose and maximize the safety profile. All three levels proved effective, continuing to successfully reduce the number and intensity of hot flushes through to the end of the 12 week study.