Positive Outcome in Phase 2 Equivalent Study for OTC Switch of STENDRA

Petros Pharmaceuticals, Inc. has announced the positive results of the initial cohort of a Phase 2 self-selection study for its erectile dysfunction medication, STENDRA, which aims to transition from prescription to over-the-counter (OTC) status. The study demonstrated that over 78% of participants correctly selected to use STENDRA with the aid of a technology application, versus 56% who only used the Drug Facts Label (DFL).

The success of this initial study part will lead to a larger cohort study. Results from this expansion are expected by the end of 2024. Fady Boctor, President and Chief Commercial Officer of Petros, emphasized the role of their technology platform in achieving accurate consumer self-selection and mentioned that the organization has shared these findings with the U.S. Food and Drug Administration (FDA). The company anticipates continued collaboration with the FDA, aiming to provide further updates and integrate AI tools for better outcomes.

The study was structured as an open-label, two-arm trial. Participants were divided into groups: one using the DFL alone and the other using both the DFL and a technology-assistive app. The study design followed FDA guidelines for self-selection and aimed to validate the effectiveness of the new technology in enabling proper consumer choices, as outlined in the proposed Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU) rule.

In light of these successful results, Petros Pharmaceuticals is gearing up for the next cohort phase, with more participants evaluated using just the DFL. The following stage will include a larger population and reintroduce the technology component alongside DFL. This strategic approach aligns with ongoing discussions with the FDA, which focuses on providing consumers with adequate information for self-selection and ensuring appropriate medication use in non-prescription settings.

Petros Pharmaceuticals is a company dedicated to becoming a leader in the self-care industry by expanding access to prescription drugs via OTC designations. Their main focus currently is on making STENDRA accessible as an OTC medication, which would be a significant milestone as it could be the first erectile dysfunction drug to achieve OTC status. This move would not only benefit Petros but also establish their platform as a model for converting other prescription medications to OTC status.

Switching a prescription drug to an OTC format involves numerous steps, including developing a user-friendly Drug Facts Label and testing it to ensure consumers can make informed decisions based on the label alone. This process usually requires Label Comprehension Studies (LCS), Self-Selection Studies (SSS), and Actual Use Trials (AUT) to demonstrate safe and appropriate consumer use in a simulated OTC environment.

The latest FDA regulations introduce ACNU criteria which could facilitate OTC access for drugs previously limited to prescription-only availability. This includes innovative tools and strategies that support the transition from prescription to OTC.

STENDRA (avanafil), an oral phosphodiesterase 5 (PDE5) inhibitor, originally launched by Auxilium Pharmaceuticals, is specifically designed for treating erectile dysfunction. While effective in men, its safety and efficacy in women and children remain untested. The tablets can be taken approximately 15 minutes before sexual activity and should not be used more than once a day. Common side effects include headache, flushing, nasal congestion, and back pain. Safety precautions must be followed, especially in patients with cardiovascular issues or those taking other medications that can interact negatively with STENDRA.

Petros Pharmaceuticals continues its efforts towards realizing STENDRA's OTC potential, reflecting its commitment to expanding consumer access to essential medications.