Petros Pharmaceuticals Developing First-in-Industry SaaS Platform Utilizing AI and Electronic Health Records Intended to Facilitate Rx-OTC Switches
Petros Pharmaceuticals (NASDAQ:PTPI) is developing a pioneering SaaS platform designed to facilitate prescription to over-the-counter (Rx-OTC) drug transitions. The platform integrates AI, electronic health records, and cybersecurity components to support pharmaceutical companies in making prescription medications available over the counter.
The platform aligns with the FDA's Additional Conditions for Nonprescription Use (ACNU) guidelines and President Trump's Make America Healthy Again (MAHA) initiative. Potential applications include treatments for erectile dysfunction, high cholesterol, migraine, anxiety, and urinary tract infections. The platform will feature patient self-selection tools, health records integration, and potential retail pharmacy integration.
The self-care market is currently valued at $38 billion with an expected 5.6% CAGR over the next decade. The company has completed eight studies to support its development, including Formative Human Factors Studies and Application Comprehension Studies.
Petros Pharmaceuticals (NASDAQ:PTPI) sta sviluppando una piattaforma SaaS innovativa progettata per facilitare la transizione da farmaci con prescrizione a farmaci da banco (Rx-OTC). La piattaforma integra componenti di intelligenza artificiale, cartelle cliniche elettroniche e sicurezza informatica per supportare le aziende farmaceutiche nel rendere disponibili i farmaci da prescrizione senza ricetta.
La piattaforma è conforme alle linee guida FDA sulle Condizioni Aggiuntive per l'Uso Senza Prescrizione (ACNU) e all'iniziativa Make America Healthy Again (MAHA) del Presidente Trump. Le applicazioni potenziali includono trattamenti per disfunzione erettile, colesterolo alto, emicrania, ansia e infezioni del tratto urinario. La piattaforma offrirà strumenti per l'auto-selezione del paziente, integrazione delle cartelle cliniche e possibile integrazione con farmacie al dettaglio.
Il mercato dell'autocura è attualmente valutato a 38 miliardi di dollari con un tasso di crescita annuo composto (CAGR) previsto del 5,6% per il prossimo decennio. L'azienda ha completato otto studi a supporto dello sviluppo, inclusi Studi Formativi sui Fattori Umani e Studi di Comprensione dell'Applicazione.
Petros Pharmaceuticals (NASDAQ:PTPI) está desarrollando una plataforma SaaS pionera diseñada para facilitar la transición de medicamentos con receta a medicamentos de venta libre (Rx-OTC). La plataforma integra componentes de IA, registros electrónicos de salud y ciberseguridad para apoyar a las compañías farmacéuticas en hacer que los medicamentos con receta estén disponibles sin receta.
La plataforma se alinea con las directrices de la FDA sobre Condiciones Adicionales para Uso Sin Receta (ACNU) y con la iniciativa Make America Healthy Again (MAHA) del presidente Trump. Las aplicaciones potenciales incluyen tratamientos para disfunción eréctil, colesterol alto, migraña, ansiedad e infecciones del tracto urinario. La plataforma contará con herramientas de auto-selección para pacientes, integración de registros de salud y posible integración con farmacias minoristas.
El mercado de autocuidado está valorado actualmente en 38 mil millones de dólares con un crecimiento anual compuesto (CAGR) esperado del 5.6% durante la próxima década. La compañía ha completado ocho estudios para apoyar su desarrollo, incluyendo Estudios Formativos de Factores Humanos y Estudios de Comprensión de Aplicaciones.
Petros Pharmaceuticals (NASDAQ:PTPI)는 처방약에서 일반의약품(Rx-OTC)으로 전환을 용이하게 하는 혁신적인 SaaS 플랫폼을 개발 중입니다. 이 플랫폼은 인공지능, 전자 건강 기록, 사이버 보안 요소를 통합하여 제약 회사들이 처방약을 일반의약품으로 제공할 수 있도록 지원합니다.
플랫폼은 FDA의 비처방 사용 추가 조건(ACNU) 지침과 트럼프 대통령의 Make America Healthy Again(MAHA) 이니셔티브에 부합합니다. 적용 가능 분야는 발기부전, 고콜레스테롤, 편두통, 불안, 요로감염 치료 등이 포함됩니다. 플랫폼은 환자의 자가 선택 도구, 건강 기록 통합, 소매 약국과의 통합 가능성을 특징으로 합니다.
자가 관리 시장은 현재 380억 달러 규모이며 향후 10년간 연평균 성장률 5.6%이 예상됩니다. 회사는 개발 지원을 위해 인간 요인 형성 연구 및 응용 이해 연구를 포함한 8건의 연구를 완료했습니다.
Petros Pharmaceuticals (NASDAQ:PTPI) développe une plateforme SaaS innovante conçue pour faciliter la transition des médicaments sur ordonnance vers les médicaments en vente libre (Rx-OTC). La plateforme intègre des composants d'IA, dossiers médicaux électroniques et cybersécurité pour aider les entreprises pharmaceutiques à rendre les médicaments sur ordonnance accessibles sans ordonnance.
La plateforme est conforme aux directives de la FDA concernant les Conditions Supplémentaires pour l’Usage Sans Ordonnance (ACNU) et à l’initiative Make America Healthy Again (MAHA) du président Trump. Les applications potentielles incluent les traitements pour la dysfonction érectile, le cholestérol élevé, la migraine, l’anxiété et les infections urinaires. La plateforme proposera des outils d’auto-sélection pour les patients, une intégration des dossiers médicaux et une possible intégration avec les pharmacies de détail.
Le marché de l’autosoins est actuellement évalué à 38 milliards de dollars avec un taux de croissance annuel composé (CAGR) prévu de 5,6% pour la prochaine décennie. L’entreprise a réalisé huit études pour soutenir son développement, incluant des études formatives sur les facteurs humains et des études de compréhension de l’application.
Petros Pharmaceuticals (NASDAQ:PTPI) entwickelt eine bahnbrechende SaaS-Plattform, die den Übergang von verschreibungspflichtigen zu rezeptfreien Medikamenten (Rx-OTC) erleichtern soll. Die Plattform integriert Künstliche Intelligenz, elektronische Gesundheitsakten und Cybersicherheit, um Pharmaunternehmen zu unterstützen, verschreibungspflichtige Medikamente rezeptfrei verfügbar zu machen.
Die Plattform entspricht den FDA-Richtlinien zu zusätzlichen Bedingungen für die nicht verschreibungspflichtige Verwendung (ACNU) und der Make America Healthy Again (MAHA) Initiative von Präsident Trump. Mögliche Anwendungen umfassen Behandlungen für Erektile Dysfunktion, hohen Cholesterinspiegel, Migräne, Angstzustände und Harnwegsinfektionen. Die Plattform wird Werkzeuge zur Patientenselbstselektion, Integration von Gesundheitsakten und mögliche Integration in Einzelhandelsapotheken bieten.
Der Selbstpflege-Markt hat derzeit einen Wert von 38 Milliarden US-Dollar mit einer erwarteten durchschnittlichen jährlichen Wachstumsrate (CAGR) von 5,6% über das nächste Jahrzehnt. Das Unternehmen hat acht Studien zur Unterstützung der Entwicklung abgeschlossen, darunter formative Human Factors Studien und Studien zum Anwendungsverständnis.
- Development of innovative SaaS platform could create new revenue streams through licensing to pharmaceutical companies
- Platform aligns with FDA guidelines and recent executive orders, potentially accelerating adoption
- Large addressable market with self-care sector valued at $38 billion and growing at 5.6% CAGR
- Company has completed 8 studies validating their approach
- Multiple potential applications across various therapeutic areas including erectile dysfunction, cholesterol, and anxiety medications
- Platform is still in development phase with no guaranteed success
- Significant competition likely in the Rx-OTC transition technology space
- Complex regulatory environment could delay implementation
- Integration with existing healthcare systems and pharmacies may present challenges
Insights
Petros shifts strategy to develop SaaS platform facilitating Rx-OTC switches, aligned with regulatory trends, but remains in early development stages.
Petros Pharmaceuticals is announcing a strategic pivot toward becoming a healthcare technology company through development of a SaaS platform designed to facilitate prescription-to-OTC drug switches. This platform aims to integrate with their Software as Medical Device (SaMD) consumer interface to help pharmaceutical companies navigate the FDA's Additional Conditions for Nonprescription Use (ACNU) regulatory framework.
The company is positioning this platform within the context of President Trump's recent Executive Order to expand medication access through OTC approvals. Their solution appears to target pharmaceutical companies facing lifecycle management decisions for established drugs. The press release identifies several therapeutic areas they believe are appropriate for Rx-to-OTC switches, including erectile dysfunction, high cholesterol, migraine, anxiety and urinary tract infections.
This announcement represents a developmental strategy rather than a completed product launch. The language throughout uses future-oriented terms like "being designed," "intended to," and "developmental" - indicating early-stage development. While the company mentions completing 8 research studies to inform development, no efficacy data or validation metrics are provided.
The self-care market referenced as their target is substantial at $38 billion with projected 5.6% annual growth, but the serviceable portion specific to Rx-to-OTC technology platforms remains undefined. The announcement lacks concrete details on development timeline, potential partners, revenue model, or financial projections that would help assess near-term impact. This appears to be primarily a directional announcement rather than one with immediate revenue implications.
The technology platform Petros is developing represents an interesting application of digital health capabilities to address regulatory complexities. Their approach combines several advanced technologies: a SaaS enterprise platform integrated with AI algorithms, electronic health records, and cybersecurity safeguards.
What makes this technically notable is the attempt to systematize the complex requirements of the FDA's ACNU framework through technology. The platform appears designed to provide standardized patient self-selection tools and health record integration that could potentially make Rx-to-OTC switches more feasible for pharmaceutical companies.
However, the technical challenges involved shouldn't be underestimated. Integrating with diverse electronic health record systems presents significant interoperability hurdles. Ensuring appropriate AI decision support while maintaining regulatory compliance requires sophisticated validation. The cybersecurity and privacy safeguards mentioned are essential but increasingly complex given healthcare data regulations.
The company doesn't detail their technical capabilities, development team composition, or technology partners that would be executing this vision. They mention "retail integration" and "commercial scalability" which suggests pharmacy point-of-sale integration - another complex technical challenge requiring partnerships with retail pharmacy systems.
While the conceptual application of technology to solve regulatory challenges is innovative, the press release provides limited technical specifics on implementation approach, technology stack, development milestones, or validation methodologies. Without these details, it's difficult to assess the technical feasibility of their proposed solution or timeline to market readiness.
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
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
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.
View the original press release on ACCESS Newswire
FAQ
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