Petros Pharmaceuticals, Inc. announced the successful completion of the initial cohort of a Phase 2 equivalent Self-Selection Study (SSS). The study demonstrated that more than 78% of subjects utilizing the technology assistive application correctly self-selected to use STENDRA (avanafil) compared to 56% of subjects who utilized the Drug Facts Label (DFL) alone. The open-label, two arm self- selection study was designed to evaluate the ability of the participant to obtain a correct self- selection outcome with the Drug Facts Label alone (Arm 1) compared to the DFL and the technology-assistive app (Arm 2).

The design is based on principles from FDA's Guidance for Self-Selection[1] and was intended to demonstrate the value of the proposed technology, according to the proposed Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) rule. These results have informed the development of the soon-to-be-launched second cohort of the Phase 2 equivalent SSS utilizing a larger subject population and the Drug Facts Label alone, in accordance with ongoing discussions with the FDA. The Company then plans to conduct a larger population SSS which will again include the technology component.

Petros Pharmaceuticals continues its collaboration with the FDA in its pursuit to bring prescription STENDRA over the counter as it provides insight on the effectiveness of the Company's delivery of appropriate use drug facts and their comprehension in a consumer setting.