EvaMistTreatment for Postmenopausal Symptoms
Update: Evamist Now FDA Approved - July 27, 2007
VIVUS Announces FDA Acceptance of EvaMist NDA Submission
EvaMist is an Investigational Drug for the Treatment of Menopausal Symptoms
MOUNTAIN VIEW, Calif., December 12, 2006 -- VIVUS, Inc. , a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products addressing obesity and sexual health, today announced that the new drug application (NDA) filed by the company for EvaMist was accepted for review by the U.S. Food and Drug Administration (FDA) as a new treatment for vasomotor symptoms associated with menopause.
VIVUS announced positive results from its pivotal Phase 3 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.
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. EvaMist is a small, hand-held, simple-to- use spray that is designed to provide an easy and convenient means to deliver a preset dose of estradiol via 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. EvaMist is easily administered as one, two or three sprays.
"We are pleased to announce the FDA acceptance of our submission for EvaMist," stated Leland F. Wilson, president and chief executive officer for VIVUS. "We are already working with the agency and look forward to gaining regulatory approval of this important new treatment for women suffering with the symptoms of menopause."
VIVUS' Phase 3 study assessed the safety and efficacy of EvaMist for the treatment of hot flashes in menopausal women. The Phase 3 trial, which was 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. This study was conducted under a Special Protocol Assessment (SPA) from the FDA. Results showed that EvaMist decreased the number of hot flashes by 78%, from 10.8 hot flashes per day at baseline to 2.3 hot flashes after treatment. This decrease was statistically significant compared to placebo (p<0.0001). The reduction in frequency and severity of moderate to severe hot flashes was statistically significant over placebo for all three doses of EvaMist evaluated. Importantly, application site irritation was 1.5% and was typically mild in nature.
VIVUS believes EvaMist may offer significant advantages over oral, gel and patch hormone replacement products. EvaMist is a small, hand-held, simple-to- use spray that is designed to provide an easy and convenient means to deliver a preset dose of estradiol via the skin. EvaMist is placed gently against the skin and an actuator button is pushed, releasing a light spray containing a proprietary formulation of estradiol. Estradiol is released into the blood stream on a sustained basis over 24 hours. EvaMist is fast drying, non- irritating and invisible after application.
Approximately two million American women turn 50 each year. Women naturally enter into menopause usually between the ages of 45 and 55; however, surgical menopause may happen at any age. Menopausal symptoms occur when the ovaries stop producing estrogen. Symptoms include hot flashes, discomfort or pain during sexual intercourse due to vaginal atrophy (thinning of the vagina), and changes in skin and hair.
Source: VIVUS, Inc.
Posted: December 2006
- KV Pharmaceutical Announces U.S. Food and Drug Administration Approval of EvaMist - July 30, 2007
- VIVUS Submits New Drug Application With U.S. Food and Drug Administration for EvaMist - October 2, 2006