Petros Pharmaceuticals Strategically Positioned to Benefit as Technology Leader from Newly Approved FDA OTC Final Rules
Petros Pharmaceuticals (NASDAQ:PTPI) announces its strategic positioning following FDA's final rule approval for 'Nonprescription Drug Product with an Additional Condition for Nonprescription Use' (ACNU). The company has developed a proprietary technology platform incorporating AI and quantum computing to facilitate Rx-to-OTC drug switches.
The company's platform, developed under FDA guidance and feedback, aims to assist pharmaceutical companies in pursuing Rx-to-OTC switches. Petros believes its technology, enhanced by quantum computing capabilities, could create significant partnership opportunities with pharmaceutical companies looking to extend their products' commercial viability through OTC switches.
The self-care market, where Petros aims to operate, is currently valued at over $38 billion with an expected 5.6% compound annual growth rate over the next decade.
Petros Pharmaceuticals (NASDAQ:PTPI) annuncia il suo posizionamento strategico a seguito dell'approvazione finale da parte della FDA della regola per 'Prodotto Farmaceutico Nonprescrittivo con un'Ulteriore Condizione per Uso Nonprescrittivo' (ACNU). L'azienda ha sviluppato una piattaforma tecnologica proprietaria che incorpora AI e calcolo quantistico per facilitare i passaggi da farmaci su prescrizione a farmaci da banco (Rx-to-OTC).
La piattaforma dell'azienda, sviluppata sotto la guida e il feedback della FDA, mira ad assistere le aziende farmaceutiche nel perseguire i passaggi Rx-to-OTC. Petros crede che la sua tecnologia, potenziata dalle capacità di calcolo quantistico, potrebbe creare opportunità di partnership significative con aziende farmaceutiche che cercano di estendere la commerciabilità dei loro prodotti attraverso i passaggi OTC.
Il mercato dell'auto-cura, in cui Petros mira a operare, è attualmente valutato oltre 38 miliardi di dollari con un tasso di crescita annuo composto del 5,6% previsto per il prossimo decennio.
Petros Pharmaceuticals (NASDAQ:PTPI) anuncia su posicionamiento estratégico tras la aprobación de la regla final de la FDA para 'Producto Farmacéutico No Prescriptivo con una Condición Adicional para Uso No Prescriptivo' (ACNU). La empresa ha desarrollado una plataforma tecnológica propietaria que incorpora IA y computación cuántica para facilitar la transición de medicamentos con receta a medicamentos de venta libre (Rx-to-OTC).
La plataforma de la empresa, desarrollada bajo la guía y retroalimentación de la FDA, tiene como objetivo ayudar a las compañías farmacéuticas a llevar a cabo cambios de Rx a OTC. Petros cree que su tecnología, mejorada por las capacidades de computación cuántica, podría crear oportunidades significativas de asociación con empresas farmacéuticas que buscan extender la viabilidad comercial de sus productos a través de cambios a OTC.
El mercado del autocuidado, en el que Petros pretende operar, está actualmente valorado en más de 38 mil millones de dólares con una tasa de crecimiento anual compuesta del 5.6% esperada para la próxima década.
페트로스 제약 (NASDAQ:PTPI)는 '비처방 약품에 대한 추가 조건을 갖춘 비처방 용도' (ACNU)에 대한 FDA의 최종 규칙 승인을 따르는 전략적 포지셔닝을 발표했습니다. 이 회사는 처방약에서 일반약으로의 전환을 지원하기 위해 AI와 양자 컴퓨팅을 통합한 독점 기술 플랫폼을 개발했습니다.
FDA의 지침과 피드백에 따라 개발된 이 플랫폼은 제약 회사들이 Rx-OTC 전환을 추구하는 데 도움을 주는 것을 목표로 하고 있습니다. 페트로스는 양자 컴퓨팅 기능에 의해 향상된 기술이 OTC 전환을 통해 제품의 상업적 생존 가능성을 확대하려는 제약 회사들과의 중요한 파트너십 기회를 창출할 수 있다고 믿고 있습니다.
페트로스가 운영할 예정인 자가 관리 시장은 현재 380억 달러 이상으로 평가되며, 향후 10년 동안 연평균 성장률 5.6%이 예상됩니다.
Petros Pharmaceuticals (NASDAQ:PTPI) annonce son positionnement stratégique suite à l'approbation finale par la FDA de la règle pour 'Produit Médical Non Prescription avec une Condition Additionnelle d'Utilisation Non Prescription' (ACNU). L'entreprise a développé une plateforme technologique propriétaire intégrant l'IA et l'informatique quantique pour faciliter les changements de médicaments sur ordonnance à médicaments en vente libre (Rx-to-OTC).
La plateforme de l'entreprise, développée sous la direction et les retours de la FDA, vise à aider les entreprises pharmaceutiques à poursuivre les transitions Rx vers OTC. Petros croit que sa technologie, renforcée par les capacités de l'informatique quantique, pourrait créer des opportunités de partenariat significatives avec des entreprises pharmaceutiques cherchant à prolonger la viabilité commerciale de leurs produits grâce aux changements OTC.
Le marché des soins autogérés, où Petros vise à opérer, est actuellement évalué à plus de 38 milliards de dollars, avec un taux de croissance annuel composé de 5,6% prévu pour la prochaine décennie.
Petros Pharmaceuticals (NASDAQ:PTPI) gibt seine strategische Positionierung nach der endgültigen Regelgenehmigung der FDA für 'Nichtverschreibungspflichtiges Arzneimittel mit zusätzlicher Bedingung für nicht verschreibungspflichtige Verwendung' (ACNU) bekannt. Das Unternehmen hat eine proprietäre Technologieplattform entwickelt, die KI und Quantencomputing integriert, um den Übergang von Rx zu OTC-Arzneimitteln zu erleichtern.
Die Plattform des Unternehmens, die unter Anleitung und Feedback der FDA entwickelt wurde, zielt darauf ab, Pharmaunternehmen bei der Verfolgung von Rx-OTC-Umstellungen zu unterstützen. Petros glaubt, dass seine Technologie, die durch die Fähigkeiten des Quantencomputings verbessert wurde, bedeutende Partnerschaftsmöglichkeiten mit Pharmaunternehmen schaffen könnte, die beabsichtigen, die kommerzielle Lebensfähigkeit ihrer Produkte durch OTC-Umstellungen zu verlängern.
Der Selbstpflege-Markt, in dem Petros tätig sein möchte, wird derzeit auf über 38 Milliarden Dollar geschätzt und wird in den nächsten zehn Jahren eine jährliche Wachstumsrate von 5,6% erwarten.
- Company's proprietary technology platform aligns with new FDA ACNU guidelines
- Targeting $38 billion self-care market with 5.6% CAGR
- Technology platform integrates advanced AI and quantum computing capabilities
- No immediate revenue generation from the technology platform mentioned
- Success depends on future pharmaceutical partnerships that are not yet secured
Insights
Proprietary technology developing quantum computing and applying AI to better enable Rx to OTC switch candidates across multiple indications
NEW YORK, NY / ACCESSWIRE / January 7, 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 its conducive position in connection with the recently issued final rule, "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. The Company's recently announced shift in its primary business strategy was initially developed under guidance of earlier iterations of the rule, and the Company believes the final rule will help facilitate the development of 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, "Over the course of the development of our technology solution, we carefully followed the direction of ACNU guidance, and incorporated periodic feedback from the FDA to address key FDA concerns. With the ACNU rule now approved and adopted, we are gratified to be at the forefront of the FDA's emerging requirements for Rx-to-OTC switches. Further, we believe our previous experience in development, combined with our ongoing FDA discussions and our pursuit to integrate additional technologies like AI and quantum computing, will help to position us as leaders in this growing sector."
Petros has developed 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, combined with the processing and calculative power of quantum computing, 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
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 accesswire.com
FAQ
What is the significance of FDA's ACNU rule for PTPI's business strategy?
How large is the market opportunity for PTPI's Rx-to-OTC switch technology?
What technologies is PTPI incorporating in its Rx-to-OTC switch platform?
How does PTPI plan to monetize its Rx-to-OTC switch technology?
