Vivus Could File Evamist Menopause Spray By Year-End
This article was originally published in The Pink Sheet Daily
Executive Summary
Transdermal estradiol spray significantly reduces hot flashes in Phase III trial.
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Vivus plans to submit an NDA for topical estradiol spray Evamist in the second half of 2006 following positive Phase III results, the firm announced May 5. Results of the 12-week randomized study of 457 menopausal women found that the most effective of three Evamist doses decreased hot flashes by 78%, from 10.7 to 2.3 per day. All three doses evaluated in the study yielded statistically significant reductions in frequency and severity of moderate to severe hot flashes. The metered-dose transdermal spray is titrated between one, two and three sprays. Vivus CEO Leland Wilson called Evamist a "unique and easy-to-use product." According to Vivus, "Evamist is fast drying, non-irritating and invisible after application....Once administered, Evamist's formulation is not affected by washing and does not transfer to partners." The study of the first-in-class product was conducted under an FDA special protocol assessment, agreed upon in 2004 (1 (Also see "Vivus Evamist Menopause Spray To Start Phase III Under Special Protocol Assessment" - Pink Sheet, 16 Dec, 2004.)). Estradiol is currently available in tablet, topical emulsion/gel, transdermal patch and intravaginal ring formulations. The company said it plans to market the product through its current internal sales force. -Mary Bruce |