Vivus and Auxilium announced that the Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Stendra (avanafil) to be take taken early as ~15 minutes before sexual activity in the treatment of erectile dysfunction.
Stendra, a phosphodiesterase type 5 (PDE5) inhibitor, was initially approved in 2012 to be taken approximately 30 minutes before sexual activity.
The sNDA approval of Stendra was based on results from Study TA-501, which was designed to assess efficacy of 2 dosage strengths of Stendra as early as ~15 minutes after dosing (n=440). In the study, patients treated with Stendra had a significantly higher proportion of attempts that enabled an erection sufficient for successful sexual intercourse as early as ~15 minutes compared to placebo.
Stendra is available in 50mg, 100mg, and 200mg strength tablets in 30- and 100-count bottles