Vivus says Evamist spray reduces menopause symptoms by 78%

By Elaine Rigoli

Tampa, Fla., May 5 - Vivus, Inc. said results from the pivotal phase 3 clinical trial of Evamist showed that the most effective Evamist dose significantly decreased the number of hot flashes by 78%, from 10.7 hot flashes per day at baseline to 2.3 hot flashes after treatment.

The study showed a statistically significant reduction in the number and severity of moderate and severe hot flashes for all three doses tested, the company said in a news release.

The trial, conducted at 43 clinical sites in the United States, 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.

Evamist is a once-daily transdermal spray that delivers estradiol, a naturally occurring estrogen, for the treatment of hot flashes in women.

This study was conducted under a Special Protocol Assessment from the Food and Drug Administration.

Based in Mountain View, Calif., Vivus develops proprietary products to restore sexual function for women and men.

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