Petros announces results from analysis of STENDRA self-selection study

Petros Pharmaceuticals announced results of a subsequent analysis of its pivotal study aimed at facilitating FDA-approved OTC access of the Company’s STENDRA for consumers. This analysis suggested support for the primary study results and demonstrated improved correct self-selection outcomes resulting from patients using the Company’s proprietary Web App Technology and its embedded clinically validated diagnostic tool relative to subsequent verbal interviews that were designed into the study protocol as a form of validation of an ED diagnosis. The analysis shows that men seem to respond with more transparency to clinically validated, yet intimate, erectile diagnostic questions discretely compared to a live interview, illustrating a disparity between the Web App results and the live interview determinations. The initial results from the proprietary technology arm demonstrated a 90.6% Point Estimate and an 86.37% Lower Bound for correct self-selection, while the post hoc analysis demonstrated a 94.9% PE and a 91.51% LB, a rate of self-selection of 4.3% and 5.14% higher, respectively. The statistically significant higher instance of correct self-selection compared to Drug Facts Label utilization alone remained unchanged. These results will be presented to the FDA in support of the results shown in the study in relation to the study endpoints reflected in the study protocol. As reported previously, the study, which evaluated 509 subjects, demonstrated a 90.6% PE correct consumer self-selection for those who used the Company’s Web App Technology, compared to 57.3% PE 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%. Although results of the initial analysis were statistically significant showing the separation of the two arms, due to recorded accounts of patient apprehension during the live interviews that followed the patient’s discrete entries to the Company’s proprietary Web App Technology, several patients were suspected to be mis-diagnosed following the interview portion of the self-selection process, driving the Company to conduct an additional analysis using the Proprietary Web App data alone which also included a clinically validated sexual health survey often used as a standalone diagnostic tool in clinics globally. The post hoc analysis showed improved outcomes of men accurately self-selecting while using only the Proprietary Web App when removing the subsequent interview data. This analysis showed a higher point value of 94.9% correct self-selection, and a lower-bound reading of 91.51%. 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 Proprietary 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.