Petros Pharmaceuticals Strengthens Partnership with Market Leading Big Data Provider Implementing Key Enhancements to its AI Platform
Company continues to innovate and develop its SaaS-based platform to facilitate Rx-to-OTC switch in line with recent President Trump Executive Order
NEW YORK, NY / ACCESS Newswire / May 6, 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 it has implemented multiple enhancements to its developing AI platform, which is expected to improve processing and fraud detection and provide a better overall experience. The AI Platform is expected to be a key component of the Company 's recently announced SaaS-based technology, integrating Petros ' Software as a Medical Device ( "SaMD ") proprietary solution, which is being designed to help facilitate expanding access for established prescription drugs by bringing them over the counter.
The enhancements include:
Addition of Deep Fake detection and mitigation features
Improved facial and ID recognition and matching capabilities
Enhanced image auto capture feature powered by machine learning technology
Fady Boctor, Petros ' President and Chief Commercial Officer, commented, "As we seek to optimize our technology, strengthening our SaaS and SaMD features such as AI identity validation, we are committed to continuous enhancements that meet Rx-to-OTC switch requirements to keep us competitive in this market. With our experience in demonstrating the utility and value of our AI platform, each advancement builds upon an already strong foundation. Collaborating with our partner, a renowned Big Data provider, to integrate with our SaaS and SaMD template platforms is expected to establish commercially viable solutions and enable consistent and reliable results. Further, our commitment is consistent with a recently announced Executive Order from President Trump that calls for greater Rx-to-OTC switch efficiency to help increase the availability of OTC treatment options and reduce drug prices. We are committed to continuing to innovate our technology to help facilitate this demand, with a particular focus on ID verification via advanced AI capabilities, and big data integrations enabling objective qualifiers for safe and appropriate access to key therapeutics. We look forward to continuing to provide updates on all our technology enhancements. "
Petros is leading the way in its development of a proprietary SaaS and SaMD technology 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 from the Nonprescription Drug Product with an Additional Condition for Nonprescription Use " ( "ACNU ")by the United States Food and Drug Administration (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 over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years.2
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.
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 Petros Pharmaceuticals, Inc. 's ( "Petros, " "we, " "our, " "us " or 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 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
1 8 completed studies (Formative Human Factors Studies '23 & '24, Application Comprehension Studies '24, Two Arm All Comers Self Selection Study '24) - Data on file
2 Rx-to-OTC Switches Market Size, Trends & Forecast 2033 | FMI (futuremarketinsights.com)
SOURCE:Petros Pharmaceuticals, Inc.
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