Petros: 2 Upcoming FDA Review Meetings

 DA requests meeting to review the Company's technology component and discuss further development and requirements

Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has scheduled two meetings with the U.S. Food and Drug Administration (FDA) to review the Company's progress and path forward in developing STENDRA as the first PDE-5 inhibitor approved as an over-the-counter medication for erectile dysfunction. (Please see Important Safety Information below.)

The Company has scheduled a Type C meeting with the FDA on March 26, 2024, to review the Company's developing digital app for use under the FDA's Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) proposed rule.[1] Primary topics of the meeting are expected to include how to continue the development of the app, protocols for upcoming studies, including the Summative Human Factors Study. In addition, the FDA has requested a listen-only meeting during the week of March 11^th to review the app for improved productivity during the Type C meeting.

https://www.biospace.com/article/releases/petros-pharmaceuticals-announces-two-upcoming-fda-meetings-to-review-progress-and-path-forward-for-stendra-r-avanafil-rx-to-otc-switch/