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Safety, Efficacy Trial Begins for Avanafil in Erectile Dysfunction

MOUNTAIN VIEW, Calif., April 22 /PRNewswire-FirstCall/ -- Vivus, Inc. (NASDAQ:VVUS) today announced that it began enrolling patients in a clinical study designed to evaluate the safety and efficacy of avanafil (formerly TA-1790), an oral medication intended to treat erectile dysfunction (ED). This at-home, double-blind, randomized, crossover design study will enroll approximately 250 patients at 20 sites in the United States. Enrollment is anticipated to be completed by the end of 2004 and data from this study should be available during the first half of 2005.

"Our development program for avanafil continues to move ahead on schedule with initiation of this Phase 2 study," said John Dietrich vice president of Research and Development at Vivus. "One of the primary goals of this study is to confirm the appropriate dose range in a large group of patients. In addition to this Phase 2 safety and efficacy study, Vivus will initiate drug interaction studies with avanafil later this year and anticipates completing Phase 2 development in 2005."

In March 2001, VIVUS announced it had licensed avanafil, a fast-acting, highly selective, phosphodiesterase type 5 (PDE5) inhibitor from Tanabe Seiyaku Co. Ltd. a Japanese pharmaceutical company. Vivus plans to present additional, peer-reviewed results from a recently completed Phase 2 at-home study comparing avanafil to Pfizer's Viagra(R) (sildenafil) at the Western Sectional meeting of the American Urological Association (AUA) in August 2004.

Source: Vivus, Inc.

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