The FDA has approved Stendra (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S., according to biopharmaceutical company Vivus.
"Patients and treating physicians continue to report significant dissatisfaction with current treatments of ED," said Peter Tam, president, Vivus. "We believe that the PDE5 selectivity and absorption profile of Stendra make it an important new treatment option for many men with erectile dysfunction."
More than 1,200 men with ED participated in clinical studies evaluating the efficacy and safety of Stendra. Stendra at all doses tested (50mg, 100mg and 200mg) met all primary efficacy endpoints. Significant improvement in erectile function was observed for all doses in Stendra-treated patients compared to placebo.
Vivus is currently in discussion with potential partners to commercialize Stendra in the U.S. and its territories. The drug is currently approved in South Korea under the name Zepeed.