Petros Includes Nitrate Patients In OTC ED Drug Self-Selection Studies

Firms also notes in its announcement that FDA typically requires actual use trials for switch NDAs in addition to label comprehension studies, which it has conducted, and self-selection studies.

Self-selection studies starting for Petros Pharmaceuticals Inc.’s erectile dysfunction drug Stendra (avanafil), one with men also using nitrate medicines, could be pivotal to the US Food and Drug Administration’s potential reception for the firm’s planned OTC switch proposal.

“This is an important next step in the development plan to seek non-prescription status for Stendra and will inform whether...