Petros Pharmaceuticals' Proprietary Technology Demonstrates Positive Data in Pivotal Study

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, announces top-line results of its expanded Application Comprehension (“App Comp”) study, which determines consumer comprehension of its unique messaging within its proprietary Technology. In the study, the Company’s technology facilitated consumer’s understanding of designated critical objectives (with a success threshold of 90% or 85% based on clinical significance of the objective). There were an additional 17 important objectives designated without a lower bound (LB) threshold. The 400 patient-consumer study with 31 objectives in total successfully achieved 4 of 5 among the most critical objectives, 9 of 9 of the next tier critical objectives, and all 17 important objectives exceeding an 84% LB threshold.

Fady Boctor, Petros’ President and Chief Commercial Officer, commented, “This study supports our belief that, through this emerging technology, we can expand access of current Rx medications to OTC. The addition of AI and big data integration are key components to help optimize this access, and we are diligently creating a scalable Software as a Medical Device (SaMD) approach, which we believe can significantly enhance the emerging self-care market.”

This study is an extension of the previously announced initial App Comp study, which now incorporates 400 male subjects and showed patients interacting with the Company’s technology achieved 30 out of 31 objectives to the LB thresholds required for it to be meaningful to the FDA.

These results closely follow the recently adopted “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (“ACNU”) rules by the United States Food and Drug Administration (the “FDA”) for companies seeking Rx-to-OTC switch for pharmaceutical products. The Company’s development activities, which are currently integrating additional technologies like AI and big data integration position Petros to be a key player in future Rx-to-OTC switch activities within the sector.

Petro’s recently announced focus to its primary business strategy was initially developed under guidance of previous iterations of the rule, and the Company believes the final rule will help facilitate the development of its SaMD concept, which is designed to serve the emerging self-care market.

Petros has developed a proprietary technology-assisted platform that, based on multiple research studies and key enhancements, could help pharmaceutical companies pursue Rx-to-OTC switches. The Company believes that further advancement of this technology, combined with AI and big data solutions, could provide significant opportunities for future pharma partnerships among companies seeking to extend access and commercial viability of their products through an OTC switch.

The emerging self-care market is currently estimated to be valued over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years¹.

1. Rx-to-OTC Switches Market Size, Trends & Forecast 2033 | FMI (futuremarketinsights.com)

About Petros Pharmaceuticals

Petros Pharmaceuticals, Inc. is committed to the goal of becoming a leading innovator in the emerging $38 billion self-care market by providing expanded access to key prescription pharmaceuticals as OTC treatment options. The Company is currently developing a proprietary SaaS platform designed to assist pharmaceutical companies in meeting FDA standards to assist in the Rx-to-OTC switch.

About the Pathway from Rx to OTC

The process of switching a prescription medication to 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 informed 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 this, the FDA ordinarily requires a consumer tested OTC DFL. Such 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 the FDA is currently in the process of 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. Petros is developing a technology platform (SaaS) to assist companies in navigating this pathway.