Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) has announced the successful launch of its artificial intelligence (AI) tool, developed in collaboration with a major software provider, to enhance patient self-screening for Stendra (avanafil). This initiative is part of Petros's ongoing efforts to transition Stendra into the first over-the-counter (OTC) erectile dysfunction medication.
The AI tool is integrated into Petros's web application, which is currently being evaluated in a Human Factors study. This study aims to determine whether the web tool can be used safely and effectively by intended users, aligning with FDA guidance for human factors studies. Participants will perform critical tasks within the app without staff guidance.
AI-Driven Optimization for Stendra Administration
Fady Boctor, President and Chief Commercial Officer of Petros, stated, "The utilization of AI is a logical progression as we aim to optimize the safe administration of STENDRA (avanafil), in development for OTC availability." He added that the AI component directly addresses requests made by the FDA to optimize patient selection, ensuring that the drug is appropriate for each user. Petros believes it has sufficient funding to achieve its development goals and near-term clinical milestones for Stendra.
Human Factors Study Details
The Human Factors Study is designed to assess the web tool's safety and effectiveness in guiding users. The study outcomes will contribute to discussions with the FDA regarding the need for Additional Conditions of Nonprescription Use (ACNU) related to the web app and the company's OTC development efforts for Stendra.
The OTC Pathway for Stendra
The process of switching a prescription medication to OTC involves designing a Drug Facts Label (DFL) that consumers can easily understand. Data must demonstrate that consumers can make appropriate decisions about using the product based solely on the DFL and their medical history. Consumers must also show they can properly use the product based on the DFL information. The FDA typically requires a consumer-tested OTC DFL, including Label Comprehension Studies (LCS), Self-Selection Studies (SSS), and an Actual Use Trial (AUT).
The FDA is currently finalizing regulations that introduce Additional Conditions for Nonprescription Use (ACNU) criteria, which may expand OTC access to medications previously available only by prescription. An ACNU may involve an innovative computerized tool or other approaches to support the switch process.
About Stendra (avanafil)
Stendra is an oral phosphodiesterase 5 (PDE5) inhibitor for treating erectile dysfunction. A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. Stendra only works with sexual stimulation and should not be taken more than once a day. Common side effects include headache, flushing, nasal congestion, nasopharyngitis, and back pain.
