Petros Pharmaceuticals announces outcomes in label comprehension study

Petros Pharmaceuticals announces completion of a pivotal label comprehension study. Using FDA guidance provided to the company in 2022, the LCS is expected to satisfy a critical step in the organization’s progress towards a possible non-prescription version of STENDRA, the Company’s prescription erectile dysfunction drug. Akin to a Phase 2a study in clinical development sequencing, this study’s purpose is to evaluate the nonprescription Drug Facts Label and consumer comprehension of key guidelines for safe and appropriate use. The study required a consumer to read the Drug Facts Label, then answer a series of use-case scenario questions during a live virtual interview. Powered by a 95% Confidence Interval, the study protocol included approximately 29 primary endpoint questions designed to evaluate the consumer’s understanding of the particular use-case with target thresholds ranging from 90% to 95% comprehension respectively. Results showed significant comprehension among the 480 subjects.