This phase III trial is a multi-center, 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 US. The study was initiated in December 2004 under a special protocol assessment (SPA) with the FDA.
The SPA is a formal agreement that designates the agreed upon terms and conditions under which Vivus will conduct and analyze the data from its phase III trial. The SPA provides official confirmation from the FDA that the protocol design is sufficient for a phase III trial which, if completed as agreed, can form the basis of the submission of a new drug application (NDA).
“Completion of enrollment in the pivotal phase III trial for Evamist represents yet another corporate milestone for Vivus,” said Peter Tam, senior vice president of product and corporate development of Vivus. “We believe Evamist has the potential to provide a practical and convenient option for the millions of women seeking a better treatment option for their menopausal symptoms.”