NEW YORK - Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) has announced the results of a study indicating that the use of a web app in conjunction with a Drug Facts Label (DFL) significantly aids consumers in the correct self-selection of over-the-counter (OTC) medications. In a recent trial, a subgroup of patients using both the web app and DFL demonstrated a 100% rate of correct self-selection, a notable improvement over the 40% rate observed when patients used the DFL alone.
The study, which is part of the company's efforts to secure OTC status for its erectile dysfunction therapy STENDRA (avanafil), involved 30 participants. Findings revealed that approximately 86% of users correctly self-selected when using the combined approach of the DFL and web app, compared to only 56% who used the DFL alone.
This data is expected to support discussions with the U.S. Food and Drug Administration (FDA) about the need for the Additional Condition of Nonprescription Use (ACNU) in the form of the web app.
Fady Boctor, Petros' President and Chief Commercial Officer, stated that the trial serves as a preliminary version of their pivotal Phase 2 study, which began earlier this month. The company aims to provide the FDA with evidence that consumers can determine the appropriateness of using STENDRA without a physician's prescription.
The results are particularly significant for the subgroup of nitrate users, a high-concern population for the FDA, as they showed a 100% correct self-selection rate with the technology. Boctor expressed optimism about the potential for STENDRA to become the first OTC prescription-grade therapeutic option for erectile dysfunction and highlighted the company's sufficient funding to achieve its development goals.
Petros Pharmaceuticals specializes in expanding consumer access to medication through OTC drug development programs. The process for transitioning a prescription medication to OTC involves creating a DFL that consumers can understand and demonstrating through studies that consumers can make appropriate decisions based on the label and their medical history.
The information in this article is based on a press release.
InvestingPro Insights
Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) has made strides with its study results, which could have a significant impact on its quest to secure OTC status for STENDRA. As the company navigates this pivotal moment, investors are closely monitoring its financial health and stock performance. Here are some key insights from InvestingPro that could inform stakeholders about the company's current standing:
InvestingPro Data:
- The company holds a modest Market Cap of approximately $3.08M USD, reflecting its position in the market.
- Revenue has shown impressive growth over the last twelve months as of Q3 2023, with an increase of 61.43%, and a quarterly surge of 214.88% in Q1 2023.
- Despite its revenue growth, the company's P/E Ratio stands at -0.23, with an adjusted P/E Ratio for the same period at -0.24, indicating challenges in profitability.
InvestingPro Tips:
- PTPI's stock has experienced significant volatility, with a notable decline over the last week and month, which could be a point of concern for potential investors.
- The company has more liquid assets than short-term obligations, which is a positive sign of financial stability.
These insights suggest that while Petros Pharmaceuticals is pushing forward with its OTC drug development, the stock's recent performance and profitability issues are areas that investors may want to watch closely. For those considering a deeper dive into PTPI, InvestingPro offers additional insights and metrics. By using the coupon code PRONEWS24, readers can get an extra 10% off a yearly or biyearly Pro and Pro+ subscription to access the full suite of InvestingPro Tips, which currently includes six more tips related to PTPI.
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