FDA added approval for Stendra in Erectile Dysfunction

Vivus and Auxilium Pharmaceuticals have announced that the FDA has approved a supplemental new drug application (sNDA) for Stendra (avanafil). Stendra is now the only FDA-approved Erectile Dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity. Approval is based on results from Study TA-501 entitled, "A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction."

The study was designed to assess the efficacy of two dosage strengths of Stendra as early as approximately 15 minutes after dosing. In this 440-patient study conducted at 30 sites in the U.S., patients treated with Stendra had a significantly higher proportion of attempts that enabled an erection sufficient for successful sexual intercourse as early as approximately 15 minutes following administration compared to placebo. The previously approved prescribing information recommended administration approximately 30 minutes before sexual activity.