FDA Approves sNDA for Oral Erectile Dysfunction Treatment

September 18, 2014
HCPLive Staff

The FDA has approved a supplemental new drug application for avanafil (Stendra) to treat erectile dysfunction in men.

VIVUS, Inc. and Auxilium Pharmaceuticals, Inc. today announced that the FDA has approved a supplemental new drug application for avanafil (Stendra), a phosphodiesterase type 5 inhibitor that treats erectile dysfunction (ED) in men aged 18 years and older.

According to a news release from the companies, Stendra “is available in multiple dosage strengths (50, 100 and 200 mg tablets) and may be taken with or without food and moderate alcohol consumption (up to 3 drinks).” In clinical studies, when compared to placebo, Stendra “helped more men achieve an erection in as early as approximately 15 minutes that lasted long enough to successfully complete sexual intercourse.”

Based on data from the Massachusetts Male Aging Study, researchers estimate that 52% of men over 40 years of age experience some degree of ED, defined as “the inability to attain or maintain a penile erection for sufficient sexual performance.”

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