Petros Pharmaceuticals' Proprietary Technology Demonstrates Positive Data in Pivotal Study
Petros Pharmaceuticals (NASDAQ:PTPI) has announced positive results from its expanded Application Comprehension study, testing its proprietary technology for Rx-to-OTC drug switches. The 400-patient study evaluated 31 objectives, successfully achieving 4 of 5 most critical objectives, all 9 second-tier critical objectives, and all 17 important objectives with an 84% lower bound threshold.
The technology, enhanced with AI and big data integration, is being developed as a Software as a Medical Device (SaMD) platform. This aligns with the FDA's recently adopted 'Nonprescription Drug Product with an Additional Condition for Nonprescription Use' (ACNU) rules for Rx-to-OTC switches.
The company aims to position itself as a key player in the self-care market, currently valued at over $38 billion with an expected 5.6% compound annual growth rate over the next decade. The platform could potentially facilitate pharmaceutical companies in pursuing Rx-to-OTC switches, extending access and commercial viability of their products.
Petros Pharmaceuticals (NASDAQ:PTPI) ha annunciato risultati positivi dal suo studio ampliato di Comprensione dell'Applicazione, testando la propria tecnologia proprietaria per il passaggio da farmaci da prescrizione a farmaci da banco. Lo studio, condotto su 400 pazienti, ha valutato 31 obiettivi, raggiungendo con successo 4 dei 5 obiettivi più critici, tutti i 9 obiettivi critici di secondo livello e tutti i 17 obiettivi importanti con una soglia inferiore dell'84%.
La tecnologia, potenziata con integrazione di AI e big data, è in fase di sviluppo come piattaforma Software come Dispositivo Medico (SaMD). Questo è in linea con le recenti regole adottate dalla FDA per i 'Prodotti Farmaceutici da Non Prescrizione con una Condizione Aggiuntiva per l'Utilizzo Non Prescrittivo' (ACNU) per i passaggi da Rx a OTC.
L'azienda mira a posizionarsi come un attore chiave nel mercato della cura personale, attualmente valutato oltre 38 miliardi di dollari con un tasso di crescita annuale composto previsto del 5,6% nel prossimo decennio. La piattaforma potrebbe potenzialmente facilitare le aziende farmaceutiche nel perseguire i passaggi da Rx a OTC, estendendo l'accesso e la sostenibilità commerciale dei loro prodotti.
Petros Pharmaceuticals (NASDAQ:PTPI) ha anunciado resultados positivos de su estudio ampliado de Comprensión de Aplicaciones, probando su tecnología propietaria para el cambio de medicamentos de receta a medicamentos de venta libre. El estudio, que incluyó a 400 pacientes, evaluó 31 objetivos, logrando con éxito 4 de los 5 objetivos más críticos, todos los 9 objetivos críticos de segundo nivel y todos los 17 objetivos importantes con un umbral inferior del 84%.
La tecnología, mejorada con integración de IA y big data, se está desarrollando como una plataforma de Software como Dispositivo Médico (SaMD). Esto está alineado con las reglas recientemente adoptadas por la FDA para 'Productos Farmacéuticos No Prescritos con una Condición Adicional para Uso No Prescrito' (ACNU) para el cambio de Rx a OTC.
La compañía tiene como objetivo posicionarse como un actor clave en el mercado del autocuidado, actualmente valorado en más de 38 mil millones de dólares, con una tasa de crecimiento anual compuesta esperada del 5.6% en la próxima década. La plataforma podría facilitar potencialmente a las empresas farmacéuticas en la búsqueda de cambios de Rx a OTC, ampliando el acceso y la viabilidad comercial de sus productos.
Petros Pharmaceuticals (NASDAQ:PTPI)는 처방약에서 일반의약품으로의 전환을 위한 독자적인 기술을 테스트하는 확대된 응용 이해 연구에서 긍정적인 결과를 발표했습니다. 400명의 환자를 대상으로 한 이 연구는 31개의 목표를 평가했으며, 가장 중요한 5개 목표 중 4개, 2차 중요한 9개 목표 및 17개의 중요한 목표를 모두 84%의 하한 기준으로 성공적으로 달성했습니다.
이 기술은 AI 및 빅데이터 통합으로 강화되어 의료기기 소프트웨어(SaMD) 플랫폼으로 개발되고 있습니다. 이는 Rx에서 OTC로의 전환을 위한 FDA의 최근 채택된 '비처방약 제품에 대한 추가 조건' (ACNU) 규정과 일치합니다.
회사는 현재 380억 달러 이상으로 평가되는 자기 관리 시장에서 주요 플레이어로 자리 잡는 것을 목표로 하고 있으며, 향후 10년 동안 연평균 5.6%의 성장률이 예상됩니다. 이 플랫폼은 제약회사가 Rx에서 OTC로의 전환을 추구하는 데 도움을 줄 수 있으며, 제품의 접근성과 상업적 타당성을 확장할 수 있습니다.
Petros Pharmaceuticals (NASDAQ:PTPI) a annoncé des résultats positifs de son étude élargie de Compréhension de l'Application, testant sa technologie propriétaire pour les transitions de médicaments sur ordonnance à des médicaments en vente libre. L'étude, menée sur 400 patients, a évalué 31 objectifs, atteignant avec succès 4 des 5 objectifs les plus critiques, tous les 9 objectifs critiques de deuxième niveau et tous les 17 objectifs importants avec un seuil inférieur de 84%.
La technologie, améliorée par l'intégration de l'IA et des big data, est en cours de développement en tant que plateforme de Logiciel en tant que Dispositif Médical (SaMD). Cela est en ligne avec les règles récemment adoptées par la FDA pour les 'Produits Médicamenteux Non Prescription avec une Condition Supplémentaire pour une Utilisation Non Prescription' (ACNU) pour les transitions Rx vers OTC.
L'entreprise vise à se positionner comme un acteur clé sur le marché des soins personnels, actuellement évalué à plus de 38 milliards de dollars, avec un taux de croissance annuel composé prévu de 5,6% au cours de la prochaine décennie. La plateforme pourrait potentiellement faciliter aux entreprises pharmaceutiques la poursuite des transitions Rx vers OTC, élargissant l'accès et la viabilité commerciale de leurs produits.
Petros Pharmaceuticals (NASDAQ:PTPI) hat positive Ergebnisse aus seiner erweiterten Studie zur Anwendungsverständnis bekannt gegeben, die seine proprietäre Technologie für den Wechsel von verschreibungspflichtigen Medikamenten zu rezeptfreien Medikamenten testet. Die Studie mit 400 Patienten bewertete 31 Ziele und erreichte erfolgreich 4 der 5 kritischsten Ziele, alle 9 kritischen Ziele der zweiten Ebene und alle 17 wichtigen Ziele mit einer unteren Schwelle von 84%.
Die Technologie, die mit KI- und Big-Data-Integration verbessert wurde, wird als Software als Medizinprodukt (SaMD) Plattform entwickelt. Dies steht im Einklang mit den kürzlich von der FDA angenommenen Regeln für 'Nichtverschreibungspflichtige Arzneimittel mit einer zusätzlichen Bedingung für die nichtverschreibungspflichtige Verwendung' (ACNU) für den Wechsel von Rx zu OTC.
Das Unternehmen zielt darauf ab, sich als wichtiger Akteur im Selbstpflegemarkt zu positionieren, der derzeit mit über 38 Milliarden Dollar bewertet wird und in den nächsten zehn Jahren eine voraussichtliche jährliche Wachstumsrate von 5,6% aufweist. Die Plattform könnte es Pharmaunternehmen potenziell erleichtern, Rx-zu-OTC-Wechsel zu verfolgen, den Zugang zu erweitern und die wirtschaftliche Rentabilität ihrer Produkte zu steigern.
- Successful completion of 400-patient study with 30/31 objectives meeting thresholds
- Technology aligns with new FDA ACNU regulations
- Platform targets $38B self-care market with 5.6% CAGR
- Potential for pharmaceutical partnership opportunities
- Failed to achieve 1 of 5 most critical objectives in the study
Insights
Petros Pharmaceuticals (NASDAQ:PTPI) has announced promising results from its expanded Application Comprehension study, demonstrating that its proprietary technology successfully met 30 out of 31 objectives considered meaningful to FDA standards. This represents a significant milestone in the company's strategy to facilitate Rx-to-OTC switches across multiple therapeutic areas.
The technology's performance is particularly noteworthy in the context of the FDA's recently adopted ACNU (Additional Condition for Nonprescription Use) framework, which creates a regulatory pathway for prescription medications to transition to over-the-counter status when supported by appropriate technological safeguards. By achieving high comprehension rates across critical objectives, Petros has demonstrated that its Software as a Medical Device (SaMD) approach could potentially unlock significant value in the pharmaceutical industry.
What makes this development particularly significant is the integration of AI and big data capabilities into the platform. This technological enhancement could address one of the primary challenges in Rx-to-OTC switches: ensuring consumers can appropriately self-select, self-diagnose, and safely use medications without physician oversight. The study's focus on 400 male subjects suggests initial applications in men's health, likely targeting erectile dysfunction medications – a market with substantial OTC potential.
For investors, this represents a potential value creation opportunity through multiple revenue streams: licensing the technology to pharmaceutical companies seeking to extend product lifecycles, developing internal OTC candidates, or pursuing strategic partnerships. The self-care market's projected growth to exceed $38 billion with a 5.6% CAGR underscores the substantial addressable market.
However, several critical factors warrant investor attention. With a micro-cap valuation of approximately $1.3 million, Petros faces significant financial constraints that could limit its ability to fully capitalize on this technology without additional funding or partnerships. The company's extremely low market capitalization suggests substantial execution risk and likely near-term capital needs.
Additionally, the path to commercialization remains lengthy. While the App Comp study results are encouraging, developing a fully validated SaMD platform, securing regulatory clearance, and establishing commercial partnerships will require substantial time and investment. The company will need to demonstrate that its technology can be successfully applied across diverse therapeutic areas beyond its initial focus.
The announcement represents a potentially transformative development for Petros, but investors should recognize that significant execution challenges remain before this technology translates into sustainable revenue growth and shareholder value. The company's ability to secure strategic partnerships, address capital requirements, and navigate the complex regulatory landscape for digital health technologies will be critical factors determining long-term success in this promising but competitive space.
Proprietary technology utilizing AI and big data integrations to enable Rx to OTC switch candidates across multiple indications
NEW YORK, NY / ACCESS Newswire / February 25, 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, announces top-line results of its expanded Application Comprehension ("App Comp") study, which determines consumer comprehension of its unique messaging within its proprietary Technology. In the study, the Company's technology facilitated consumer's understanding of designated critical objectives (with a success threshold of
Fady Boctor, Petros' President and Chief Commercial Officer, commented, "This study supports our belief that, through this emerging technology, we can expand access of current Rx medications to OTC. The addition of AI and big data integration are key components to help optimize this access, and we are diligently creating a scalable Software as a Medical Device (SaMD) approach, which we believe can significantly enhance the emerging self-care market."
This study is an extension of the previously announced initial App Comp study, which now incorporates 400 male subjects and showed patients interacting with the Company's technology achieved 30 out of 31 objectives to the LB thresholds required for it to be meaningful to the FDA.
These results closely follow the recently adopted "Nonprescription Drug Product with an Additional Condition for Nonprescription Use" ("ACNU") rules by the United States Food and Drug Administration (the "FDA") for companies seeking Rx-to-OTC switch for pharmaceutical products. The Company's development activities, which are currently integrating additional technologies like AI and big data integration position Petros to be a key player in future Rx-to-OTC switch activities within the sector.
Petro's recently announced focus to its primary business strategy was initially developed under guidance of previous iterations of the rule, and the Company believes the final rule will help facilitate the development of its SaMD concept, which is designed to serve the emerging self-care market.
Petros has developed a proprietary technology-assisted platform that, based on multiple research studies and key enhancements, could help pharmaceutical companies pursue Rx-to-OTC switches. The Company believes that further advancement of this technology, combined with AI and big data solutions, 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 ACCESS Newswire
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