Market Overview

VIVUS Announces Acceptance of Avanafil Application in Europe


VIVUS,Inc. (Nasdaq: VVUS) today announced that a Marketing Authorization Application has been accepted by the European Medicines Agency for the review of avanafil, its investigational drug for the treatment of erectile dysfunction. The EMA submission follows the successful completion of an extensive phase 3 program for avanafil, which included over 1,350 patients.

"The unique profile of avanafil, including its onset of action and highly selective profile, make it an attractive treatment alternative for the more than 20 million European men suffering with ED," stated Francesco Montorsi, MD, Professor of Urology and Director of the Urology Research Institute at the Universita' Vita e Salute San Raffaele in Milan, Italy. "Successful intercourse was reported in some patients in as little as 15 minutes after dosing. The comprehensive results from the development program suggest avanafil, if approved, could effectively compete in the $4 billion worldwide ED market."

The MAA includes results from three placebo-controlled, randomized, double-blind, multicenter studies: REVIVE, which included 646 men from the general population with ED, REVIVE-Diabetes, which included 390 diabetics, and REVIVE-RP, which included 298 men following radical prostatectomy. Also included are the results from the year-long safety study, TA-314, which included 712 continuation patients from the REVIVE and REVIVE-Diabetes studies.

Posted-In: News FDA Global


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