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Vivus' Stendra approved for ED

Friday, April 27 2012 | Comments
Evidence Grade 0 What's This?
Vivus Inc. received approval from the Food and Drug Administration to market Stendra (avanafil) as a treatment for erectile dysfunction (ED).

Stendra, a highly selective phosphodiesterase type 5 inhibitor, is the first new prescription drug approved for ED in nearly a decade, Vivus noted.

The efficacy and safety of the drug was evaluated in three clinical trials involving a total of 1,267 men with ED. Stendra successfully met all primary efficacy endpoints, resulting in statistically significant improvement in erectile function at all dose levels tested (50 mg, 100 mg and 200 mg) in comparison with placebo.

Vivus said it is in discussions with potential partners to commercialize Stendra in the United States and in its territories elsewhere. The company licensed the drug from Mitsubishi Tanabe Pharma Corp., thereby gaining development and commercial rights to Stendra for the treatment of sexual dysfunction worldwide except in certain Asian Pacific Rim countries.

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