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MMOUNTAIN VIEW, Calif., and CHESTERBROOK, Pa. — VIVUS Inc. and Auxilium Pharmaceuticals Inc. have gained Food and Drug Administration approval for a supplemental new drug application (sNDA) for Stendra, a treatment for erectile dysfunction (ED).
The companies said Thursday that Stendra (avanafil) is now the only FDA-approved ED medication indicated to be taken as early as about 15 minutes before sexual activity.
Previously, Stendra’s approved prescribing information recommended administration approximately 30 minutes before sexual activity.
"Stendra is the first FDA-approved ED drug in nearly a decade and offers men and their partners an exciting new option," stated Adrian Adams, chief executive officer and president of Auxilium Pharmaceuticals. "We believe this label expansion helps position Stendra as an exciting ‘on demand’ ED treatment and assists with the very important aspect of spontaneity for men and their partners in real-world use. We believe this provides a meaningful benefit for men with ED and further underscores Auxilium’s commitment to being an innovative leader in men’s health care."
The sNDA filed by VIVUS stemmed from the results of a study to assess the effectiveness of two dosage strengths of Stendra as early as approximately 15 minutes after dosing. The study found that patients treated with Stendra had a significantly higher proportion of attempts that enabled an erection sufficient for successful sexual intercourse as early as about 15 minutes following administration compared with placebo.
"We are pleased with the approval of the sNDA for Stendra," commented Seth Fischer, CEO of VIVUS. "The positive clinical study results, now part of the label, demonstrate Stendra’s rapid onset of action. We believe this is good news for men suffering from ED and for the health care providers who treat them."
VIVUS received FDA approval for Stendra in 2012 for the treatment of ED. Last October, the company announced an agreement giving Auxilium the exclusive rights to market Stendra in the United States and Canada.
