Petros report ‘positive’ FDA feedback after informal technology component review

Petros Pharmaceuticals announces it has received positive feedback from the U.S. Food and Drug Administration following the FDA’s informal review of Petros’ technology component for self-selection as the Company endeavors to achieve OTC status for STENDRA. The Agency acknowledged that the technology addressed some of its concerns regarding the PDE5 inhibitor class in that context, particularly with regard to nitrate-using patients. During the recent Type C meeting between Petros and the FDA, the Agency also aligned with the Company in terms of its 2H 2024 submission and review of its pivotal two-arm Self-Selection study, which is currently underway. In addition, the Company received guidance from the FDA on its next technology-centered study, the Application Comprehension Study, which will be subsequently announced following additional steps being completed.