Petros completes initial cohort of Phase 2 equivalent SSS for STENDRA

Petros Pharmaceuticals announces the completion of the initial cohort of a Phase 2 equivalent Self-Selection Study. The study demonstrated that more than 78% of subjects utilizing the technology assistive application correctly self-selected to use STENDRA compared to 56% of subjects who utilized the Drug Facts Label alone. “The success of this first part of our Phase 2 equivalent self-selection study paves the way for us to aggressively pursue a larger SSS cohort, for which we expect to have results by the end of 2024. We believe our current cash runway will be more than sufficient to complete Phase 2 equivalent which, if successful, we believe will be a significant factor in driving shareholder value. This initial cohort was a consumer-centered technology study resulting from our continued development and strengthening of our technology platform as we continue our efforts for an Rx-to-OTC switch for STENDRA,” stated Fady Boctor, Petros’s President and CCO. “These results, along with all our work over the last year, have been submitted to the U.S. Food and Drug Administration for review with the intention of continuing our discussions with the Agency on a viable pathway to OTC. We look forward to providing updates on further development, including the prospects of integrated AI tools, and additional opportunities to meet and share these outcomes with the FDA in the first half of 2024.” 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 compared to the DFL and the technology-assistive app. The design is based on principles from FDA’s Guidance for Self-Selection 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 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.