VIVUS SUBMITS APPLICATION FOR ESTRADIOL SPRAY

VIVUS has submitted a new drug application to the FDA for its investigational estradiol drug, EvaMist, being developed for the treatment of vasomotor symptoms associated with menopause.

VIVUS announced positive results from its Phase III 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, conducted at 43 clinical sites in the United States, 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. 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 per day after treatment. This decrease was statistically significant compared with placebo. The reduction in frequency and severity of moderate to severe hot flashes was statistically significant over placebo for all three doses.

EvaMist is a once-a-day transdermal spray that delivers estradiol, a naturally occurring estrogen, for the treatment of hot flashes in women. EvaMist is a small, hand-held spray that is designed to provide an easy and convenient means to deliver a preset dose of estradiol via the skin. Studies have shown that once administered, EvaMist's formulation is not affected by washing and does not transfer to other people.