New FDA-Approved Labeling for Petros Pharmaceuticals’ STENDRA (avanafil) Now Includes Efficacy Data Regarding Use in Men Who Have Undergone Radical Prostatectomy

Expanded STENDRA Labeling Now Includes Data on a Significant Population of Men Not Previously Included Following Submission of Additional Clinical Trial Data

NEW YORK, NY / ACCESSWIRE / October 25, 2022 / Petros Pharmaceuticals, Inc. (Nasdaq:PTPI), a leading provider of therapeutics for men's health, today announces 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.

"Our ongoing goal remains to expand access of STENDRA to as many men who need it as possible," commented Fady Boctor, Petros's President and Chief Commercial Officer. "Whether it is through a label expansion that now includes a significant population of men who were not covered under the previous labeling, or ultimately applying to ensure that STENDRA can be obtained OTC, we believe every opportunity to increase the availability of STENDRA is an opportunity to improve the lives of more men who suffer from ED. We are grateful to the FDA for their ongoing collaboration in this label expansion and will continue to work closely with the Agency moving forward."

About STENDRA^® (avanafil)

STENDRA^® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. STENDRA was designed and developed expressly for erectile dysfunction.