Petros Pharmaceuticals Develops Licensable AI-Enabled SaaS Platform To Help Industry Comply With Trump's MAHA Executive Order By Facilitating FDA-Guided Rx-To-OTC Drug Approvals Through A Smart Health Tech System

Licensable platform intended to facilitate industry compliance with President Trump's recent Executive Order to expand access to medicines through OTC approvals under his Make America Healthy Again (MAHA) initiative

NEW YORK, NY / ACCESS Newswire / May 1, 2025 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over the counter ("OTC") drug development programs, today announces a concerted effort toward evolving into a smart healthcare technology company through the development of a SaaS platform designed to complement its proprietary web application (also known as a Software as a Medical Device, or SaMD). The licensable platform is being designed to integrate key cloud-based components, including AI, electronic health records, cybersecurity and others to provide potential prescription treatments and pharmaceutical sponsors with a commercially viable and enterprise scaled platform. The enterprise platform is being designed within the United States Food and Drug Administration's (the "FDA") Additional Conditions for Nonprescription Use ("ACNU") guidelines to facilitate bringing prescription products over the counter, and is intended to help industry comply with President Trump's recent Executive Order to expand access to medicines through OTC approvals under his Make America Healthy Again (MAHA) initiative.

The Company is developing this intended licensable platform to provide a variety of services, including patient self-selection tools, electronic health records integration to support appropriate patient use, possible integration with retail pharmacies, and robust cybersecurity and privacy safeguards. The ACNU regulatory framework provides guidelines that are designed to expand access as pharmaceutical companies evaluate various potential switches from prescription to OTC availability.

Petros' system is being designed to meet these stipulations in an efficient, commercially viable, licensable single framework. The Company believes there are multiple indications that may be appropriate for an Rx-to-OTC switch, including erectile dysfunction, hypercholesterolemia (high cholesterol), migraine, anxiety and urinary tract infection.