Petros Pharmaceuticals, a developer of therapeutic drugs for men’s health, today announced that it has initiated two self-selecting studies for its lead product candidate, STENDRA, which is avanafil. The studies are part of the company’s efforts to submit a data package to the FDA for approval of STENDRA as an over-the-counter drug. The study helps consumers make informed decisions about a particular drug product based on their own health conditions. For the STENDRA self-selection studies, prospective users are asked to review the proposed OTC labeling and determine if the drug is or is not appropriate for them.
The results of these assessments will be shared with the FDA to help develop the company’s proposed OTC development plan. The goal of these studies is to establish if STENDRA should be classified as a non-prescription drug. This will help Petros Pharmaceuticals secure the necessary approvals for future studies. The company is pleased with the progress made so far in gathering data for the studies, which are key components of the approval process for STENDRA.