Petros Pharmaceuticals Enters AI Licensing Agreement With Leading Multi-Billion-Dollar Software Provider
Petros Pharmaceuticals, Inc. recently announced a new partnership with a leading, multi-billion-dollar AI software provider to adapt its technology for self-screening and other benefits as part of the company’s ongoing efforts to bring STENDRA over the counter. The technology will be integrated into the core tool the company has already developed as part of its Self-Selection Study, which is currently underway.
“We recognize the importance of integrating AI into our efforts to safely bring STENDRA over the counter under the FDA’s guidance and within ACNU guidance. We are utilizing proven existing technology from one of the world’s most successful and acknowledged leaders in the industry,” stated Fady Boctor, Petros’s President and Chief Commercial Officer. “As previously announced, this AI-driven technology is meant to provide an automated screening mechanism that should enhance the self-selection process and help mitigate that only men who are appropriate to use STENDRA should be able to gain access to the medication. We believe that it will be a streamlined, turn-key application, and we look forward to providing additional details both about the utilization, and the partnership itself in the coming weeks and months.”
Petros Pharmaceuticals is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-the-Counter treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, STENDRA, via potential OTC designation. If ultimately approved by the FDA for OTC access, STENDRA may be the first in its class to achieve this marketing status, also establishing company know how as a proven platform for other prospective prescription therapeutics.
The process of switching a prescription medication to over the counter (OTC) first involves the design of a Drug Facts Label (DFL) that is well understood by potential consumers. Then data must show that consumers can make an appropriate decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish these things, the FDA ordinarily requires a consumer tested OTC DFL. This testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting.
The regulations that FDA is currently finalizing introduced Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process.
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