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.
Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We believe this significant shift in our business strategy may fill an important role as many blockbuster drugs and their manufacturers face critical lifecycle management decisions. Further, as previously announced, we believe it is consistent with a recent Executive Order from President Trump, which highlights the need to create more pathways for expanded access to pharmaceutical products to help control rising healthcare costs. Finally, the expansion of access is important regardless of how it is achieved, and we believe our SaaS program will be key to overcoming longstanding challenges such as retail integration, electronic health record interoperability and the commercial scalability necessary for a true over-the-counter experience. Our developmental SaaS platform is intended to integrate seamlessly with the other key component of our strategy, the Software as a Medical Device (SaMD), which serves as the consumer interface and design engine customized to a particular therapeutic indication. We look forward to updating the progress of the development and integration of this platform."
Petros is leading the way in its development of a proprietary technology-assisted platform that, based on multiple research studies1, could help pharmaceutical companies pursue Rx-to-OTC switches. The Company believes that further advancement of this technology could provide significant opportunities for future pharma partnerships among companies seeking to extend access and commercial viability of their products through an OTC switch.
Over the course of the development of its technology solution, the Company has been carefully following the direction from recently approved guidance on the Nonprescription Drug Product with an ACNU by the FDA for companies seeking Rx-to-OTC switch for pharmaceutical products, as well as incorporating periodic feedback from the FDA to address key FDA concerns.
The emerging self-care market is currently estimated to be valued at over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years.2
8 completed studies (Formative Human Factors Studies '23 & '24, Application Comprehension Studies '24, Two Arm All Comers Self Selection Study '24) - Data on file
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 and a proprietary SaMD web application 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. Consumers must then 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 regulation that the FDA recently finalized 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.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon the Company management's assumptions, expectations, projections, intentions, and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as "intend," "develop," "goal," "plan," "predict", "may," "will," "project," "estimate," "anticipate," "believe," "expect," "continue," "potential," "opportunity," "forecast," "should," "target," "strategy" and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its proprietary Rx-to-OTC switch technology Petros' ability to comply with obligations as a public reporting company; Petros' ability to regain and maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates, including its proprietary Rx-to-OTC switch technology. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has filed, or may file, with the U.S. Securities and Exchange Commission (the "SEC") under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements.
The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws.
Contacts
Investors:
CORE IR
ir@petrospharma.com
Media:
Jules Abraham
CORE IR
917-885-7378
pr@coreir.com
SOURCE: Petros Pharmaceuticals, Inc.
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