Petros Pharmaceuticals has successfully completed a Formative Human Factors study for its AI-integrated Web App, a crucial step towards making STENDRA® (avanafil) available over-the-counter (OTC) for erectile dysfunction. The study, designed to meet FDA requirements for Rx-to-OTC switches, demonstrated the app's effectiveness in guiding consumers through the self-selection process.
The Web App achieved a 90% or better error-free completion rate across nearly 5,820 tasks. This success allows Petros to advance its program and refine the AI features of the app. Fady Boctor, President and Chief Commercial Officer of Petros, expressed optimism, highlighting the potential for Petros to be a pioneer in the OTC access category.
Study Details and AI Integration
The Formative Human Factors study involved 30 consumers, including individuals with limited literacy. Participants completed 194 different tasks using the Web App without prior training. A proprietary AI interface verified consumer identity, a first in Rx-to-OTC switch programs.
Rx-to-OTC Switch Process and FDA Regulations
Switching a prescription drug to OTC requires demonstrating that consumers can understand the Drug Facts Label (DFL), make informed decisions about using the product, and use it correctly based on the DFL information. The FDA typically requires Label Comprehension Studies (LCS), Self-Selection Studies (SSS), and an Actual Use Trial (AUT).
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.
About Stendra (avanafil)
STENDRA® (avanafil) is an oral phosphodiesterase 5 (PDE5) inhibitor for treating erectile dysfunction. It is not intended for use by 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.
Petros Pharmaceuticals aims to increase access to Stendra, potentially making it the first in its class to gain OTC status, pending FDA approval. Achieving this would also establish Petros as a platform for other prescription-to-OTC transitions.
