Petros Pharmaceuticals Completes AI-Integrated Study for STENDRA OTC Switch

Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a New York-based company dedicated to expanding over-the-counter (OTC) drug availability, has successfully completed a Formative Human Factors study for its AI-integrated Web App. This innovation is aimed at facilitating OTC access to STENDRA® (avanafil), a medication primarily used for erectile dysfunction, under the guidance of the U.S. Food and Drug Administration (FDA).

The Web App, an essential part of Petros' initiative to switch STENDRA® from prescription (Rx) to OTC, achieved a 90% or better error-free completion rate across nearly 5,820 tasks. This milestone follows the company's recent AI licensing agreement with a major software provider earlier this year. The study's success marks a significant step forward for Petros, allowing the company to proceed with the next phase of its program while enhancing the AI features of the Web App.

Petros' President and Chief Commercial Officer, Fady Boctor, expressed optimism about the results, noting that the positive outcomes are encouraging signs of progress in the Rx-to-OTC switch for STENDRA®. Boctor emphasized the company's potential to be a pioneer in the OTC access category, highlighting that the ongoing refinements based on FDA interactions and study insights are crucial for the program's optimization.

The Formative Human Factors study involved 30 consumers, including a subset with limited literacy. Participants were tasked with correctly demonstrating 194 different tasks using the Web App without any prior training or guidance. The study also featured a proprietary AI interface that verified consumer identity, marking a first in Rx-to-OTC switch programs.

Petros Pharmaceuticals aims to be a leading innovator in the self-care market, focusing on making prescription pharmaceuticals available as OTC treatments. The company is currently working towards increasing access to its flagship erectile dysfunction therapy, STENDRA® (avanafil), potentially making it the first in its class to gain OTC status, pending FDA approval. Achieving this would also establish Petros as a proven platform for other prescription-to-OTC transitions.

The process of switching a prescription drug to OTC involves several steps, starting with the creation of a Drug Facts Label (DFL) that consumers can easily understand. Data must demonstrate that consumers can make informed decisions about using the product based solely on the DFL and their medical history. They must also show they can use the product correctly 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) for safe and appropriate use in a simulated OTC setting.

Recent FDA regulations introducing Additional Conditions for Nonprescription Use (ACNU) aim to support correct self-selection by consumers, potentially expanding OTC access to medications previously available only by prescription. These conditions may involve innovative tools like computerized systems to aid the switch process.

STENDRA® (avanafil) is an oral phosphodiesterase 5 (PDE5) inhibitor for treating erectile dysfunction, not intended for women or children. Clinical trials have shown some side effects, such as headache, flushing, and nasal congestion, with a small percentage of participants discontinuing use due to these effects. The medication should not be used with certain other drugs or by individuals with specific health conditions.

In summary, Petros Pharmaceuticals' successful completion of the Formative Human Factors study for its AI-integrated Web App is a significant advancement toward making STENDRA® (avanafil) available OTC. This development aligns with the company's mission to enhance consumer access to crucial medications, positioning Petros as a leader in the emerging self-care market.

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