The FDA announced that it has approved Stendra (avanafil; Vivus Inc.) tablets for the treatment of erectile dysfunction.

Stendra’s safety and efficacy were established in three double-blind, placebo-controlled clinical studies. A total of 1,267 patients randomized to doses of 50mg, 100mg, 200mg, or a placebo as needed about 30 minutes before sexual activity for up to 12 weeks. Patients completed questionnaires to evaluate erectile function, vaginal penetration and successful intercourse. Results showed patients taking Stendra experienced statistically significant improvement in all three endpoints for all three doses of Stendra studied.

Stendra, a phosphodiesterase type 5 (PDE5) inhibitor, helps increase blood flow to the penis.

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