VIVUS COMPLETES ENROLLMENT IN STUDY OF EVAMIST

VIVUS has completed enrollment in its pivotal Phase III clinical study of its investigational drug Evamist (Estradiol MDTS), an estradiol spray for the treatment of vasomotor symptoms associated with menopause. This trial is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Evamist. The primary endpoint is the reduction in the frequency and severity of moderate-to-severe vasomotor symptoms associated with menopause at weeks four and 12 of the study. Over 400 patients were enrolled at 43 centers throughout the U.S. The study was initiated in December 2004 under a special protocol assessment with the FDA.

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. The Evamist applicator is placed gently against the skin and an actuator button is pushed. A light spray containing a proprietary formulation of estradiol is then released, where it is absorbed into the dermal layer. This method of delivery eliminates the requirement to touch the formulation, and may decrease the transfer of the active ingredient to other areas of the body or to other persons. Estradiol is released into the blood stream on a sustained basis over 24 hours.