Pharmaceuticals Company Announces Results of Study For OTC Access To ED Drug
Petros Pharmaceuticals' STENDRA® (Avanafil) Pivotal Consumer Self-Selection Study for Over-the-Counter Access Demonstrates Statistical Significance
Disclaimer: The following article is intended for informational and educational purposes only. It does not constitute medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), commonly referred to as "Petros" or "the Company," has recently announced the results of a pivotal study aimed at enabling over-the-counter (OTC) access to STENDRA® (avanafil). This development represents a step forward in the Company’s mission to expand consumer access to medication through innovative OTC drug development programs. The primary goal of this study was to facilitate the FDA-approved OTC availability of STENDRA®, a drug traditionally used to treat erectile dysfunction.
Study Overview
The pivotal self-selection study employed a novel approach by integrating Petros’ proprietary Web App Technology to assist consumers in making appropriate selections regarding their eligibility to use STENDRA®. The study compared the effectiveness of this technology against the traditional Drug Facts Label (DFL) method alone. The results demonstrated a statistically significant improvement in correct consumer self-selection when using the Web App Technology. A total of 509 subjects participated in this randomized, two-arm, open-label, virtual self-selection study. Participants were divided into two groups:
Arm A: Participants used the DFL alone to determine their eligibility to use STENDRA®.
Arm B: Participants used the DFL in conjunction with the Company’s Web App Technology.
The findings of the study were striking. The group utilizing the Web App Technology (Arm B) had a 90.6% accuracy rate in correct consumer self-selection, whereas those relying solely on the DFL (Arm A) had an accuracy rate of 57.3%. This difference was statistically impactful (p<0.001), showing the efficacy of the Web App Technology in guiding consumers. Notably, the high-risk population, specifically those identifying as nitrate users, also showed improvement. This subgroup achieved a 98.21% correct self-selection rate with the Web App Technology, compared to a 58.7% rate with the DFL alone. This 67% differential highlights the enhanced safety provided by the technology, ensuring that high-risk individuals make informed decisions.
Commentary from Petros Pharmaceuticals
Fady Boctor, President and Chief Commercial Officer of Petros Pharmaceuticals, emphasized the importance of these findings. According to Mr. Boctor, the data “clearly demonstrate the value of our proprietary Web App Technology in improving consumers' ability to make appropriate self-selections.” He further noted that these results bolster the Company’s position under the Additional Conditions for Nonprescription Use (ACNU) criteria. ACNU status could ultimately enable expanded OTC access to medications that previously required prescriptions.
Mr. Boctor also mentioned that the Company is eager to continue collaborating with the FDA. The next steps involve sharing this data and progressing towards an "actual use" trial, akin to a Phase 3 clinical trial, which is necessary before filing a New Drug Application (NDA). This pivotal self-selection study followed a rigorous design to meet FDA standards. Conducted as a randomized, two-arm, open-label virtual study, it aimed to objectively compare participant self-selection using the DFL alone versus the DFL plus Web App Technology. According to the FDA’s Proposed Rule for a Nonprescription Product with an Additional Condition of Nonprescription Use (ACNU), sponsors must demonstrate that labeling alone is insufficient to ensure appropriate self-selection or actual use. Given these requirements, the results from the study provide critical evidence to support the argument that additional technological interventions are necessary to guide consumer behavior effectively.
Petros Pharmaceuticals remains committed to advancing its OTC drug development program. The Company plans to conduct further pivotal trials to gather comprehensive data necessary for the FDA's evaluation. Additionally, Petros is focused on integrating and optimizing artificial intelligence (AI) into its technology to address ongoing FDA concerns and enhance consumer guidance. The results of this self-selection study mark a milestone in Petros’ journey toward making STENDRA® accessible OTC. The demonstrated efficacy of the Web App Technology not only supports the Company’s application for ACNU status but also sets a precedent for future OTC transitions for prescription drugs.
Petros Pharmaceuticals' pivotal self-selection study for STENDRA® demonstrates a enhancement in correct consumer self-selection when using the Company's Web App Technology compared to the DFL alone. With a strong focus on regulatory collaborations and technological advancements, Petros continues to pave the way for expanded OTC access to essential medications. The Company’s commitment to leveraging technology for better consumer outcomes could potentially transform the landscape of OTC drug availability, offering more accessible healthcare solutions to the public.
Disclaimer: This article is intended for informational and educational purposes only. It does not constitute medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
Real-time information is available daily at https://stockregion.net