FDA Grants Meeting To Petros Pharma To Discuss Label Expansion Of ED Drug Stendra - Quick Facts

(RTTNews) - Petros Pharmaceuticals, Inc. (PTPI), a provider of therapeutics for men's health, announces Tuesday that it has been granted a meeting with the U.S. Food and Drug Administration (FDA) to discuss expansions and modifications to the labeling of its erectile dysfunction (ED) medication Stendra (avanafil). The meeting is currently scheduled for September, 2021.

The company will discuss with U.S. regulatory authorities steps toward potential new labeling with regard to use in patients who have undergone radical prostatectomy, endothelial function, dosing flexibility and the nitrate contraindication.

Stendra (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an FDA-approved, prescription oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of ED.