Petros Pharmaceuticals, Inc. announced positive results of an initial cohort of its self-selection study comparing the use of a Drug Facts Label (DFL) alone to a DFL in combination with a web app (technology component). In the 30-person study, approximately 86% of users of the DFL and technology component (Arm B) correctly self-selected, compared to only 56% of users who used the DFL alone (Arm A). These data are intended to provide directional evidence to further discussions with the U.S. Food and Drug Administration (FDA) regarding the need for the Additional Condition of Nonprescription Use (ACNU) in the form of the web app.

Importantly, this initial study included a subgroup of nitrate users (n=9) who demonstrated 100% correct self-selection when using the app-technology (n=4) compared to only 40% of similar participants (n=5) in the DFL-only arm. As previously disclosed, the Company anticipates that in the event positive self-selection data are achieved following this study and the ongoing pivotal self-selection studies, and upon FDA study clearance, it would expeditiously initiate an actual use trial, akin to a Phase 3 registration trial in clinical development sequencing.