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Petros begins enrollment in AI integrated Human Factors Study to optimize self-screening, continuing its efforts to make STENDRA (avanafil) the first erectile dysfunction medication to achieve OTC Status
Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has successfully launched its artificial intelligence (AI) tool developed as a result of its collaboration with a multi-billion-dollar software developer. The tool is being integrated into the Company's web app being used for patient self-screening, which it is testing in its recently launched Human Factors study.
Fady Boctor, Petros' President and Chief Commercial Officer, commented, "The utilization of AI is a logical progression as we aim to optimize the safe administration of STENDRA (avanafil), in development for OTC availability. In addition, based on our recent interaction with the FDA on our technology approach, we believe the AI component directly addresses requests made by the Agency in order to optimize selection. Ultimately, we believe the AI will help us to gather information to ensure that the patient is appropriate to receive the drug. Importantly, we continue to believe that we have sufficient funding to achieve our development goals as well as significant near-term clinical milestones for STENDRA."
The Human Factors Study, which incorporates the AI tool, is designed to assess whether the web tool developed by the company can be used safely and effectively by its intended users. Subjects will be asked to perform critical tasks with the web app without any guidance from the study staff. The study is based on applicable FDA guidance for human factors studies. The outcomes from this study will further contribute to discussions with the U.S. Food and Drug Administration (FDA) regarding the need for the Additional Condition of Nonprescription Use (ACNU) with regard to the web app and the Company's endeavors to develop STENDRA into the first erectile dysfunction medication to go OTC.
Posted In: PTPI
