The study showed a statistically significant reduction in the number and severity of moderate and severe hot flashes for all three doses tested. The most effective Evamist dose decreased the number of hot flashes by 78%, from 10.7 hot flashes per day at baseline to 2.3 hot flashes after treatment.
After the positive results from this trial the company now plans to submit a new drug application to the FDA in the second half of 2006.
Evamist is a first-in-class transdermal spray that delivers estradiol, a naturally occurring estrogen, for the treatment of hot flashes in women. Studies have previously shown that the product’s formulation is not affected by washing and does not transfer to partners.
The phase III trial, which was conducted at 43 clinical sites in the US, was a 12-week, randomized, double-blind, placebo controlled study of 457 menopausal women. Patients were randomized into three treatment arms each administering a different dose with one, two or three sprays. The study was conducted under a special protocol assessment from the FDA.
“We believe these positive trial results along with our novel patient-preferred transdermal delivery system will establish Evamist as a superior estrogen therapy for the treatment of menopausal symptoms,” said Leland Wilson, president and CEO for Vivus.