NEW YORK - Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a leading company in the self-care medication market, announced a partnership with a prominent AI software provider to enhance its Self-Selection Study for STENDRA, potentially the first erectile dysfunction (ED) medication to be available over the counter (OTC). The collaboration aims to integrate AI technology to facilitate an automated self-screening process, ensuring only suitable candidates can access STENDRA.
The company's President and Chief Commercial Officer, Fady Boctor, emphasized the importance of AI in achieving a safe transition of STENDRA to OTC status, in line with FDA and ACNU guidance. The AI technology is expected to streamline the application process and improve self-selection accuracy. Additional details about the partnership and technology utilization are anticipated in the near future.
STENDRA, a phosphodiesterase 5 (PDE5) inhibitor, was initially launched by Auxilium Pharmaceuticals and is designed specifically for treating ED. It is not for use by women or children under 18. With the potential OTC designation, STENDRA would be a pioneering product in its class, also demonstrating Petros's capability to convert prescription treatments to OTC.
The FDA's OTC pathway involves creating a Drug Facts Label (DFL) that consumers can understand and use to make informed decisions based solely on the label and personal medical history. The process includes Label Comprehension Studies, Self-Selection Studies, and usually an Actual Use Trial to demonstrate safe and appropriate use in a simulated OTC setting.
The AI partnership aligns with Petros's strategy to expand consumer access to prescription medications as OTC options. This move could mark a significant shift in the availability of ED treatments, pending FDA approval.
The press release also included safety information about STENDRA, advising against its use with organic nitrates or for individuals with certain health conditions. Side effects reported in clinical trials include headache, flushing, and nasal congestion, among others.
This announcement is based on a press release statement, and the forward-looking information reflects the company's current expectations and projections about future events. Investors should note that actual outcomes may differ due to various risks and uncertainties.
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