Petros Pharmaceuticals to Partner with Renowned Big Data Provider to Enable Rx-to-OTC Switch Across Multiple Indications
Petros Pharmaceuticals (NASDAQ:PTPI) has announced a strategic partnership with a leading Big Data and analytics provider to enhance its AI-driven platform for Rx-to-OTC drug switches. The collaboration aims to integrate an automated credentialing solution to improve identity verification systems.
The partnership will incorporate an advanced document capture and authentication system that uses a patented global ID library to verify patient identity and eligibility. This technology will analyze ID cards through computer or mobile devices, ensuring secure authentication for medication access.
The Company is developing a proprietary technology-assisted platform as a Software-as-a-Medical Device (SaMD) concept, following FDA's guidance on Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU). This initiative targets the self-care market, currently valued at over $38 billion with an expected 5.6% annual growth rate over the next decade.
Petros Pharmaceuticals (NASDAQ:PTPI) ha annunciato una partnership strategica con un importante fornitore di Big Data e analisi per migliorare la sua piattaforma basata su AI per il passaggio da farmaci prescritti a farmaci da banco. La collaborazione mira a integrare una soluzione automatizzata di accreditamento per migliorare i sistemi di verifica dell'identità.
La partnership includerà un avanzato sistema di acquisizione e autenticazione dei documenti che utilizza una biblioteca globale di ID brevettata per verificare l'identità e l'idoneità dei pazienti. Questa tecnologia analizzerà le carte d'identità tramite computer o dispositivi mobili, garantendo un'autenticazione sicura per l'accesso ai farmaci.
L'azienda sta sviluppando una piattaforma assistita da tecnologia proprietaria come concetto di Software-as-a-Medical Device (SaMD), seguendo le linee guida della FDA sui prodotti farmaceutici da banco con una condizione aggiuntiva per l'uso non prescritto (ACNU). Questa iniziativa si rivolge al mercato dell'autocura, attualmente valutato oltre 38 miliardi di dollari con un tasso di crescita annuale previsto del 5,6% nel prossimo decennio.
Petros Pharmaceuticals (NASDAQ:PTPI) ha anunciado una asociación estratégica con un importante proveedor de Big Data y análisis para mejorar su plataforma impulsada por IA para el cambio de medicamentos de prescripción a OTC. La colaboración tiene como objetivo integrar una solución de acreditación automatizada para mejorar los sistemas de verificación de identidad.
La asociación incorporará un sistema avanzado de captura y autenticación de documentos que utiliza una biblioteca global de ID patentada para verificar la identidad y elegibilidad del paciente. Esta tecnología analizará las tarjetas de identificación a través de dispositivos informáticos o móviles, asegurando una autenticación segura para el acceso a medicamentos.
La empresa está desarrollando una plataforma asistida por tecnología propietaria como concepto de Software-as-a-Medical Device (SaMD), siguiendo las pautas de la FDA sobre productos farmacéuticos no prescritos con una condición adicional para el uso no prescrito (ACNU). Esta iniciativa se dirige al mercado del autocuidado, actualmente valorado en más de 38 mil millones de dólares con una tasa de crecimiento anual del 5.6% esperada durante la próxima década.
Petros Pharmaceuticals (NASDAQ:PTPI)는 처방약에서 일반의약품으로의 전환을 위한 AI 기반 플랫폼을 개선하기 위해 선도적인 빅데이터 및 분석 제공업체와 전략적 파트너십을 발표했습니다. 이 협력은 신원 확인 시스템을 개선하기 위해 자동화된 자격 인증 솔루션을 통합하는 것을 목표로 하고 있습니다.
파트너십은 환자의 신원과 자격을 확인하기 위해 특허받은 글로벌 ID 라이브러리를 사용하는 고급 문서 캡처 및 인증 시스템을 포함할 것입니다. 이 기술은 컴퓨터 또는 모바일 장치를 통해 신분증을 분석하여 의약품 접근을 위한 안전한 인증을 보장합니다.
회사는 비처방약품에 대한 추가 조건을 따르는 SaMD(Software-as-a-Medical Device) 개념으로 기술 지원 플랫폼을 개발하고 있습니다. 이 이니셔티브는 현재 380억 달러 이상으로 평가되는 자가 관리 시장을 목표로 하며, 향후 10년 동안 연평균 5.6%의 성장률이 예상됩니다.
Petros Pharmaceuticals (NASDAQ:PTPI) a annoncé un partenariat stratégique avec un fournisseur de Big Data et d'analytique de premier plan pour améliorer sa plateforme alimentée par l'IA pour les transitions de médicaments de prescription à OTC. La collaboration vise à intégrer une solution d'accréditation automatisée pour améliorer les systèmes de vérification d'identité.
Le partenariat comprendra un système avancé de capture et d'authentification de documents utilisant une bibliothèque mondiale d'ID brevetée pour vérifier l'identité et l'éligibilité des patients. Cette technologie analysera les cartes d'identité via des ordinateurs ou des appareils mobiles, garantissant une authentification sécurisée pour l'accès aux médicaments.
L'entreprise développe une plateforme assistée par une technologie propriétaire comme concept de Software-as-a-Medical Device (SaMD), suivant les directives de la FDA sur les produits pharmaceutiques en vente libre avec une condition supplémentaire pour un usage sans ordonnance (ACNU). Cette initiative cible le marché des soins personnels, actuellement évalué à plus de 38 milliards de dollars avec un taux de croissance annuel prévu de 5,6 % au cours de la prochaine décennie.
Petros Pharmaceuticals (NASDAQ:PTPI) hat eine strategische Partnerschaft mit einem führenden Anbieter von Big Data und Analytik angekündigt, um seine KI-gesteuerte Plattform für den Wechsel von Rx zu OTC-Arzneimitteln zu verbessern. Die Zusammenarbeit zielt darauf ab, eine automatisierte Zertifizierungslösung zu integrieren, um die Identitätsverifizierungssysteme zu verbessern.
Die Partnerschaft wird ein fortschrittliches Dokumentenerfassungs- und Authentifizierungssystem umfassen, das eine patentierte globale ID-Bibliothek verwendet, um die Identität und Berechtigung der Patienten zu überprüfen. Diese Technologie wird Ausweiskarten über Computer oder mobile Geräte analysieren und eine sichere Authentifizierung für den Zugang zu Medikamenten gewährleisten.
Das Unternehmen entwickelt eine proprietäre technologiegestützte Plattform als Konzept für Software-as-a-Medical Device (SaMD), gemäß den Richtlinien der FDA zu rezeptfreien Arzneimitteln mit einer zusätzlichen Bedingung für rezeptfreien Gebrauch (ACNU). Diese Initiative zielt auf den Selbstpflegemarkt ab, der derzeit auf über 38 Milliarden Dollar geschätzt wird und in den nächsten zehn Jahren eine jährliche Wachstumsrate von 5,6 % erwartet.
- Development of proprietary SaMD technology platform for Rx-to-OTC switches
- Partnership with leading Big Data provider enhances verification capabilities
- Targeting $38 billion self-care market with 5.6% CAGR
- Alignment with FDA guidance and regulatory requirements
- Partner identity not disclosed, indicating early-stage development
- Technology platform still in proof-of-concept phase
- No immediate revenue impact mentioned from the partnership
Insights
Petros Pharmaceuticals' strategic partnership with an unnamed Big Data provider represents a significant advancement in their core business strategy of facilitating Rx-to-OTC switches. This collaboration directly addresses one of the primary barriers to OTC conversion - ensuring appropriate patient access through robust identity verification.
The partnership enhances Petros' proprietary technology platform by incorporating automated credentialing solutions to improve their identity verification system. This positions the company to potentially capture value in the
What's particularly noteworthy is how this technology development aligns with the FDA's recently approved guidance for Nonprescription Drug Products with Additional Conditions for Nonprescription Use (ACNU). By developing technology solutions that satisfy regulatory requirements for safe OTC access, Petros is creating potential partnership opportunities with pharmaceutical companies looking to extend product lifecycles through Rx-to-OTC switches.
While the announcement lacks specific financial details and doesn't name the technology partner, this development strengthens Petros' competitive positioning in a growing market. For a microcap company with approximately
Petros' development of a Software-as-a-Medical Device (SaMD) solution represents an interesting technological approach to the Rx-to-OTC conversion challenge. The integration of AI with identity verification technology creates a specialized authentication system tailored to pharmaceutical access requirements.
The described technology solution leverages several advanced components: document capture automation, a patented global ID library, image analysis of identification cards, and database verification. This multi-layered approach to identity authentication is critical when dealing with medications that require specific patient eligibility verification.
What's technically impressive is how this system appears designed to balance security with accessibility - allowing verification via computer or mobile device while maintaining robust authentication processes. The international database component also suggests scalability beyond the U.S. market.
This approach effectively creates a digital gatekeeper for medication access, potentially replacing the traditional role of prescription verification by pharmacists. While still in pilot phase, the technology could represent a significant shift in how consumers access certain medications. The unnamed Big Data partner likely brings extensive verification databases and authentication algorithms that would be difficult and expensive for Petros to develop independently.
From a technical implementation perspective, the proof-of-concept stage indicates the system is still being refined, with publication of outcomes pending. The regulatory approval pathway for such technology-mediated access systems remains complex, but this development represents an innovative application of existing technologies to solve a specific healthcare access challenge.
Company to integrate industry leading big data technology solutions into its AI-driven platform to expand capabilities in identifying eligible patients to receive formerly Rx medications over the counter
NEW YORK, NY / ACCESS Newswire / March 20, 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 collaboration with renowned Big Data and analytics leader to enhance the development of its proprietary technology solutions designed to facilitate Rx-to-OTC switches for pharmaceutical products. The collaboration will incorporate an automated credentialing solution to help improve the Company's identity verification system, which also encompasses an AI component. The Company believes the collaboration will significantly enhance the capabilities as it develops its Software-as-a-Medical Device (SaMD) concept, which is designed to serve the emerging self-care market.
Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We continue to develop our technology incorporating AI and now this important identify verification solution to provide an optimal solution for the pharmaceutical industry to facilitate Rx-to-OTC switches for mature products. The technology partner is among the most respected developers of Big Data and analytics in the industry and their solutions will help to streamline our approach, ensuring that the right customers are requesting the right OTC products to be used safely and correctly. As our proof-of-concept pilot ensues, we plan to reveal the outcomes and name the partner accordingly. One of the biggest hurdles in the Rx-to-OTC switch is ensuring that only the right patients are receiving access to formerly prescription products. We are confident that this collaboration will be instrumental in ensuring that this additional safety measure is executed with precision and speed."
The Company's partner has developed an advanced, automated document capture and authentication system that leverages a patented global ID library to verify identity and eligibility. By analyzing an image of an ID card captured via computer or mobile device, the document capture tool ensures secure and reliable authentication to allow for access to a specific medication for which authentication is appropriate. The solution, when added to the Petros technology, will analyze an expansive international database to ensure the person's ID is authentic and corresponds to the actual patient, providing an additional level of confidence and safety.
Petros is leading the way in its development of a proprietary technology-assisted platform that, based on multiple research studies, 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 carefully followed 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
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. 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
SOURCE: Petros Pharmaceuticals, Inc.
View the original press release on ACCESS Newswire
FAQ
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