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VVUS

VIVUS Announces Positive Phase 3 Clinical Trial Results for Evamist(TM) - The First Transdermal Spray for the Treatment of Menopausal Symptoms
PR Newswire - May 05, 2006 08:01
Evamist, First Novel Transdermal Spray, Shows 78% Decrease in Moderate to Severe Hot Flashes


MOUNTAIN VIEW, Calif., May 5, 2006 /PRNewswire-FirstCall via COMTEX/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from the pivotal Phase 3 clinical trial of Evamist(TM). VIVUS' investigational estradiol metered dose transdermal spray is being developed for the treatment of vasomotor symptoms associated with menopause. 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 partners. Evamist is easily titratable between one, two or three sprays.

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 457 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 U.S. Food and Drug Administration (FDA). Results 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. 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 less than 1% and was mild in nature.

"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," stated Leland F. Wilson, president and chief executive officer for VIVUS. "We have worked diligently toward the development of this unique and easy-to-use product, and we are thrilled with the efficacy and safety demonstrated in this trial. We now look forward to filing an NDA for Evamist in the second half of 2006."

"These clinical results demonstrate Evamist's efficacy as a treatment option for the large population of women suffering from menopausal symptoms," stated Dr. John Buster, Professor, Baylor College of Medicine. "Symptoms of menopause can be devastating and debilitating. This data indicates that Evamist offers a valuable therapeutic option to this significant patient group."