VIVUS SUBMITS NDA FOR MENOPAUSE TREATMENT
Vivus announced that its new drug application (NDA) for EvaMist was accepted for review by the FDA as a new treatment for vasomotor symptoms associated with menopause.
EvaMist is a novel, once-a-day, proprietary, first-in-class transdermal spray that delivers estradiol, a naturally occurring estrogen, for the treatment of hot flashes in women. The treatment is a small, handheld spray that is designed to provide an easy and convenient means to deliver a preset dose of estradiol through the skin. EvaMist is fast-drying, non-irritating and invisible after application. Studies have shown that once administered, EvaMist's formulation is not affected by washing and does not transfer to other people.
The company announced positive results from its pivotal Phase III clinical trial of EvaMist earlier this year. The study showed a statistically significant reduction in the number and severity of moderate and severe hot flashes for all three doses tested.
The trial was conducted at 43 clinical sites in the United States and was a 12-week, randomized, double-blind, placebo-controlled study of 454 menopausal women. Patients were randomized into three treatment arms each administering a different dose with one, two or three sprays. This study was conducted under a Special Protocol Assessment from the FDA. Results showed that EvaMist decreased the number of hot flashes by 78 percent, from 10.8 hot flashes per day at baseline to 2.3 hot flashes after treatment. This decrease was statistically significant compared with placebo.