Petros announces results from STENDRA pivotal consumer self-selection study

Petros Pharmaceuticals announces results of the first of a series of pivotal studies aimed at facilitating FDA-approved OTC access of STENDRA for consumers. The pivotal self-selection study showed that consumers who used the Company’s proprietary Web App Technology, designed to assist in the appropriate consumer self-selection for receiving the drug, had a statistically significant higher instance of correct consumer self-selection, compared to those who used a Drug Facts Label alone. The study, which evaluated 509 subjects, demonstrated a 90.6% correct consumer self-selection for those who used the Company’s Web App Technology, compared to 57.3% using a DFL alone. Notably, those participants who identified as nitrate users also performed better using the Web App Technology, compared to using DFL alone, a significant difference between the two arms of the study in the high-risk population where Arm B outperformed Arm A by 67%. The pivotal self-selection study was a randomized, 2-arm, open-label, virtual, self-selection study intended to evaluate participant’s self-selection with the DFL alone compared to the participant’s self-selection with the DFL and the Web App Technology. Based on the FDA Proposed Rule for a Nonprescription Product with an Additional Condition of Nonprescription Use the sponsor must “demonstrate that the labeling alone… is insufficient to ensure appropriate self-selection or appropriate actual use, or both.” Therefore, the results of this randomized, 2-arm pivotal all-comers self-selection study are intended to provide critical evidence required by the FDA.