Petros Pharmaceuticals, Inc. announced the expansion of the FDA labeling for its oral erectile dysfunction (ED) drug, STENDRA® (avanafil), marketed by its subsidiary, Metuchen Pharmaceuticals. The expanded label now includes positive clinical trial data on STENDRA® (avanafil) use by men with ED who have undergone radical prostatectomy. The clinical trial included in the new FDA-approved labeling evaluated 286 patients with ED following radical prostatectomy in a randomized, double-blind, parallel, placebo-controlled fixed dose trial of 3 months in duration.

For study inclusion, patients had to experience ED following bilateral, nerve-sparing radical prostatectomy. Study subjects received STENDRA® (avanafil) 100 mg or 200 mg once daily. A statistically significant improvement in all 3 primary efficacy variables relative to placebo was found for both studied doses.