Petros Pharmaceuticals' Pivotal Statistically Significant Self Selection Study Shows Stronger Results with Proprietary Technology Application as Part of FDA Pathway for Over-the-Counter Access for STENDRA(R) (avanafil)
Petros Pharmaceuticals (NASDAQ:PTPI) announced improved results in its pivotal self-selection study for STENDRA® (avanafil), advancing efforts to create the first Rx-to-OTC switch in the ED category. The study, involving 509 subjects, showed a 90.6% correct consumer self-selection using the company's proprietary Web App Technology, compared to 57.3% using Drug Facts Label alone. A post hoc analysis demonstrated even stronger results, with a 94.9% point estimate and 91.51% lower bound for correct self-selection.
The Web App, featuring an embedded validated diagnostic questionnaire, outperformed live interviews, particularly for high-risk nitrate users. These statistically significant results (p<.001) support Petros' position as a candidate for the FDA's Additional Conditions for Nonprescription Use (ACNU) program, potentially expanding OTC access to STENDRA®.
Petros Pharmaceuticals (NASDAQ:PTPI) ha annunciato risultati migliorati nel suo studio cruciale di auto-selezione per STENDRA® (avanafil), avanzando gli sforzi per creare il primo passaggio da Rx a OTC nella categoria della disfunzione erettile. Lo studio, che ha coinvolto 509 soggetti, ha mostrato un 90,6% di auto-selezione corretta da parte dei consumatori utilizzando la tecnologia proprietaria Web App dell'azienda, rispetto al 57,3% utilizzando solo l'etichetta Drug Facts. Un'analisi post hoc ha dimostrato risultati ancora più forti, con una stima puntuale del 94,9% e un limite inferiore del 91,51% per l'auto-selezione corretta.
La Web App, che presenta un questionario diagnostico validato incorporato, ha superato le interviste dal vivo, in particolare per gli utenti ad alto rischio di nitrati. Questi risultati statisticamente significativi (p<.001) supportano la posizione di Petros come candidato per il programma dell'FDA sulle Condizioni Aggiuntive per l'Uso Nonprescrittivo (ACNU), potenzialmente ampliando l'accesso OTC a STENDRA®.
Petros Pharmaceuticals (NASDAQ:PTPI) anunció resultados mejorados en su estudio pivotante de auto-selección para STENDRA® (avanafil), avanzando en los esfuerzos para crear el primer cambio de Rx a OTC en la categoría de disfunción eréctil. El estudio, que involucró a 509 sujetos, mostró un 90,6% de auto-selección correcta por parte de los consumidores utilizando la tecnología de aplicación web patentada de la compañía, en comparación con un 57,3% usando solo la etiqueta de hechos del medicamento. Un análisis post hoc demostró resultados aún más sólidos, con una estimación puntual del 94,9% y un límite inferior del 91,51% para la auto-selección correcta.
La aplicación web, que cuenta con un cuestionario diagnóstico validado incorporado, superó las entrevistas en vivo, especialmente para los usuarios de nitratos de alto riesgo. Estos resultados estadísticamente significativos (p<.001) respaldan la posición de Petros como candidato para el programa de la FDA sobre Condiciones Adicionales para Uso No Prescrito (ACNU), potencialmente ampliando el acceso OTC a STENDRA®.
페트로스 제약 (NASDAQ:PTPI)는 STENDRA® (아바나필)의 주요 자기 선택 연구에서 개선된 결과를 발표하며, 발기부전(ED) 카테고리에서 첫 번째 Rx-OTC 전환을 만들기 위한 노력을 진전시키고 있습니다. 509명의 피험자가 참여한 이 연구는 회사의 독자적인 웹 앱 기술을 사용하여 90.6%의 소비자 자기 선택 정확도를 보였으며, 약물 정보 라벨만 사용했을 때는 57.3%의 정확도를 기록했습니다. 후속 분석 결과, 자기 선택의 정확도는 94.9%의 포인트 추정치와 91.51%의 하한선으로 나타났습니다.
내장된 유효성 검사된 진단 설문지를 포함한 웹 앱은 고위험 질산염 사용자에 대해 특히 라이브 인터뷰보다 우수한 성능을 보여주었습니다. 이러한 통계적으로 유의미한 결과(p<.001)는 페트로스가 FDA의 비처방 사용을 위한 추가 조건(ACNU) 프로그램의 후보로서의 입지를 지지하며, STENDRA®에 대한 OTC 접근을 확장할 수 있는 가능성을 나타냅니다.
Petros Pharmaceuticals (NASDAQ:PTPI) a annoncé des résultats améliorés dans son étude pivot de sélection autonome pour STENDRA® (avanafil), faisant progresser ses efforts pour réaliser le premier changement de Rx à OTC dans la catégorie de la dysfonction érectile. L'étude, impliquant 509 sujets, a montré un 90,6% de sélection autonome correcte par les consommateurs en utilisant la technologie Web App propriétaire de l'entreprise, contre 57,3% en utilisant uniquement l'étiquette des faits médicamenteux. Une analyse post hoc a démontré des résultats encore plus solides, avec une estimation ponctuelle de 94,9% et une limite inférieure de 91,51% pour la sélection autonome correcte.
La Web App, comprenant un questionnaire diagnostique validé intégré, a surpassé les interviews en direct, notamment pour les utilisateurs à haut risque de nitrates. Ces résultats statistiquement significatifs (p<.001) soutiennent la position de Petros en tant que candidat pour le programme des Conditions Additionnelles pour l'Utilisation Non Prescription (ACNU) de la FDA, potentiellement en élargissant l'accès OTC à STENDRA®.
Petros Pharmaceuticals (NASDAQ:PTPI) hat verbesserte Ergebnisse in seiner entscheidenden Selbstselektionsstudie für STENDRA® (Avanafil) bekannt gegeben und damit die Bemühungen vorangetrieben, den ersten Rx-OTC-Wechsel in der Kategorie der erektilen Dysfunktion zu schaffen. Die Studie, an der 509 Probanden teilnahmen, zeigte eine 90,6% korrekte Selbstselektion durch Verbraucher mithilfe der firmeninternen Web-App-Technologie, verglichen mit 57,3% nur mit dem Drug Facts Label. Eine post-hoc-Analyse ergab noch stärkere Ergebnisse mit einer punktuellen Schätzung von 94,9% und einer Untergrenze von 91,51% für die korrekte Selbstselektion.
Die Web-App, die einen eingebetteten validierten diagnostischen Fragebogen enthält, übertraf Live-Interviews, insbesondere bei Nutzern mit hohem Risikoniveau von Nitraten. Diese statistisch signifikanten Ergebnisse (p<.001) unterstützen die Position von Petros als Kandidat für das ACNU-Programm (Additional Conditions for Nonprescription Use) der FDA, was potenziell den OTC-Zugang zu STENDRA® erweitern könnte.
- 90.6% correct consumer self-selection using proprietary Web App Technology vs 57.3% with Drug Facts Label alone
- Post hoc analysis showed improved 94.9% point estimate and 91.51% lower bound for correct self-selection
- Web App outperformed live interviews, especially for high-risk nitrate users (98.21% vs 58.7%)
- Results support candidacy for FDA's ACNU program, potentially enabling OTC access to STENDRA®
- None.
Insights
Petros Pharmaceuticals' latest analysis of their pivotal study for STENDRA® (avanafil) presents compelling evidence for the efficacy of their proprietary Web App Technology in facilitating correct self-selection for erectile dysfunction (ED) treatment. The post hoc analysis revealed a 94.9% Point Estimate (PE) and a 91.51% Lower Bound (LB) for correct self-selection, which is a significant improvement over the initial results and the Drug Facts Label (DFL) alone.
The study's design, incorporating both the Web App and subsequent live interviews, inadvertently highlighted a critical insight: men appear more comfortable and truthful when answering sensitive questions about ED through a discrete, digital platform. This finding has profound implications for the future of ED diagnosis and treatment accessibility.
From a medical research perspective, the statistically significant difference (p<.001) between the Web App and DFL alone underscores the potential of digital health technologies in improving patient care. The particularly high success rate among nitrate users (98.21% PE) is especially noteworthy, as this high-risk group requires careful management.
These results strongly support Petros' candidacy for the Additional Conditions for Nonprescription Use (ACNU) program, potentially paving the way for the first-ever Rx-to-OTC switch in the ED category. This could revolutionize access to ED treatment, addressing a significant public health need while ensuring appropriate use through innovative technology.
Petros Pharmaceuticals' proprietary Web App Technology demonstrates the transformative potential of digital health solutions in pharmaceutical accessibility. The improved self-selection rates achieved through the Web App (
The Web App's success can be attributed to several key technological advantages:
- Anonymity and privacy: The digital interface provides a non-judgmental environment for users to disclose sensitive information.
- Standardization: The embedded clinically validated diagnostic questionnaire ensures consistent, high-quality data collection.
- Accessibility: Web-based platforms offer widespread reach and convenience for users.
- Data integration: The ability to seamlessly incorporate validated diagnostic tools enhances the app's effectiveness.
From a tech perspective, this study underscores the importance of user experience (UX) design in healthcare applications. The higher transparency in responses to the Web App suggests that careful consideration of user psychology in digital interface design can yield more accurate and valuable health data.
As the healthcare industry continues to evolve, we can expect to see more innovative applications of technology in areas like self-diagnosis, treatment selection and regulatory compliance. Petros' Web App sets a promising precedent for future developments in digital health and OTC medication access.
Petros Pharmaceuticals' latest study results represent a significant milestone in their pursuit of OTC status for STENDRA®. From a financial perspective, this development has several important implications:
- Market Expansion: Achieving OTC status could dramatically increase STENDRA®'s market reach, potentially leading to substantial revenue growth. The global ED market is projected to reach
$4.7 billion by 2026 and being the first OTC option could capture a significant share. - Competitive Advantage: As a potential first-mover in the OTC ED market, Petros could establish a strong brand presence and customer loyalty before competitors enter the space.
- Cost Reduction: OTC status typically reduces marketing and distribution costs associated with prescription drugs, potentially improving profit margins.
- Intellectual Property Value: The proprietary Web App Technology adds a layer of IP protection and could become a valuable asset, possibly leading to licensing opportunities or partnerships.
However, investors should also consider potential risks:
- Regulatory Hurdles: While the study results are promising, FDA approval for OTC status is not guaranteed and could face delays.
- Market Acceptance: Consumer adoption of a technology-driven OTC ED solution remains uncertain and could impact sales projections.
- Competition: Success could attract rapid competition from larger pharmaceutical companies with greater resources.
Overall, these results strengthen Petros' position in the ED market and could significantly impact its financial outlook. Investors should closely monitor the FDA's response and any updates on the ACNU program timeline.
Utilization of the Company's proprietary Web App showed improved self-selection utilizing an embedded validated diagnostic questionnaire compared to a live interview furthering the Company's efforts to potentially create a first-ever Rx-to-OTC switch in the ED category
NEW YORK, NY / ACCESSWIRE / July 29, 2024 / 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 announced results of a subsequent analysis of its pivotal study aimed at facilitating FDA-approved OTC access of the Company's STENDRA® (avanafil) for consumers. This analysis suggested support for the primary study results and demonstrated improved correct self-selection outcomes resulting from patients using the Company's proprietary Web App Technology and its embedded clinically validated diagnostic tool relative to subsequent verbal interviews that were designed into the study protocol as a form of validation of an ED diagnosis. The analysis shows that men seem to respond with more transparency to clinically validated, yet intimate, erectile diagnostic questions discretely compared to a live interview, illustrating a disparity between the Web App results and the live interview determinations. The initial results from the proprietary technology arm demonstrated a
Fady Boctor, Petros' President and Chief Commercial Officer, noted, "The new data reinforce the strong results we previously shared, highlighting that the Web App may be a more effective tool to ensure accurate self-selection. Men in the study reported that they were more comfortable answering questions about their condition anonymously on the Web App than in a live interview. This additional analysis further demonstrates the value of our proprietary Web App Technology, showcasing a significant impact on guiding consumers to appropriate self-selection and strengthening our position as a candidate for the upcoming Additional Conditions for Nonprescription Use ("ACNU") program, which is designed to enable expanded OTC access to medications that previously required a prescription. We look forward to future discussions with the FDA and to continued collaboration on this important path for improved medication accessibility."
As reported previously, the study, which evaluated 509 subjects, demonstrated a
Although results of the initial analysis were statistically significant showing the separation of the two arms, due to recorded accounts of patient apprehension during the live interviews that followed the patient's discrete entries to the Company's proprietary Web App Technology, several patients were suspected to be mis-diagnosed following the interview portion of the self-selection process, driving the Company to conduct an additional analysis using the Proprietary Web App data alone which also included a clinically validated sexual health survey often used as a standalone diagnostic tool in clinics globally. The post hoc analysis showed improved outcomes of men accurately self-selecting while using only the Proprietary Web App when removing the subsequent interview data. This analysis showed a higher point value of
The pivotal self-selection study was a randomized, 2-arm, open-label, virtual, self-selection study intended to evaluate participant's self-selection with the DFL alone (Arm A) compared to the participant's self-selection with the DFL and the Proprietary Web App Technology (Arm B). Based on the FDA Proposed Rule for a Nonprescription Product with an Additional Condition of Nonprescription Use (ACNU)1 the sponsor must "demonstrate that the labeling alone… is insufficient to ensure appropriate self-selection or appropriate actual use, or both." Therefore, the results of this randomized, 2-arm pivotal all-comers self-selection study are intended to provide critical evidence required by the FDA.
About Petros Pharmaceuticals
Petros Pharmaceuticals, Inc. is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as OTC treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, STENDRA® (avanafil), via potential OTC designation (see important safety information below.) If ultimately approved by the FDA for OTC access, STENDRA® (avanafil) may be the first in its class to achieve this marketing status, also establishing company know how as a potentially proven platform for other prospective prescription therapeutics.
About the OTC Pathway
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 FDA is currently 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.
Important Safety Information about STENDRA® (avanafil)
STENDRA® (avanafil), originally launched by Auxilium Pharmaceuticals prior to its sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA® (avanafil) is not for use in women or children. It is not known if STENDRA® (avanafil) is safe and effective in women or children under 18 years of age. A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA® (avanafil) only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA® (avanafil) (for example, more than three glasses of wine or three shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials,
STENDRA is contraindicated for any form of organic nitrates, in patients with known hypersensitivity to any component of the tablet, and in patients who are using a guanylate cyclase stimulator.
Patients should not use STENDRA if sexual activity is inadvisable due to cardiovascular status or any other reason. Before taking STENDRA, tell your doctor if you have had any kind of heart issues including heart attack, heart failure, angina and irregular heartbeat or have elevated or low blood pressure.
Use of STENDRA with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than three units) may lead to hypotension.
Patients should seek emergency treatment if an erection lasts greater than 4 hours.
Patients should stop STENDRA and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non-Arteritic Ischemic Optic Neuropathy ("NAION"). Doctors should discuss with patients the increased risk of NAION in patients with a history of NAION.
Patients should stop taking STENDRA and seek prompt medical attention in the event of sudden decrease or loss of hearing.
STENDRA can potentiate the hypotensive effect of nitrates, alpha blockers, antihypertensives, and alcohol.
CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, erythromycin) increase STENDRA exposure. For patients taking concomitant strong CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin), do not use STENDRA.
Combination with Other PDE5 Inhibitors or Erectile Dysfunction Therapies is not recommended.
The safety of STENDRA is unknown in patients with bleeding disorders and patients with active peptic ulceration.
The use of STENDRA offers no protection against sexually transmitted diseases including HIV. Consider counseling patients on protective measures for sexually transmitted diseases.
The most common adverse reactions reported with use of STENDRA include headache, flushing, nasal congestion, nasopharyngitis, and back pain.
For more information about STENDRA, call 844-458-4887 . If you would like to report an adverse event or product complaint, please contact us at 844-458-4887.
You are encouraged to report negative side effects of prescription drugs to the FDA by calling 1-800-FDA-1088, or at www.fda.gov/medwatch.
Please see the full Prescribing Information and Patient Information.
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 product candidates; 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; risks related to Petros' dependence on the commercialization of a single product, STENDRA®; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates. 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
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