NEW YORK - Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a leader in over-the-counter drug development, has announced promising results from its initial study evaluating consumer comprehension of its App Technology in relation to their flagship erectile dysfunction therapy, STENDRA® (avanafil). The study aimed to assess how well patients understand the messaging within the app compared to the current Drug Facts Label.
The study tested comprehension of 31 distinct messages displayed on both desktop and mobile devices. The results showed high levels of understanding among participants, with 29 objectives scoring over 90% comprehension, 30 above 86.7%, and all surpassing 80%. Notably, 21 scored a perfect 100% comprehension.
These results are part of Petros' ongoing efforts to meet FDA requirements for converting prescription medications to over-the-counter status. The company is currently conducting a larger scale study to confirm these findings, which is expected to involve around 400 patients and conclude by Q4 2024.
Fady Boctor, Petros' President and Chief Commercial Officer, expressed optimism regarding the progress of the App Technology and its potential to facilitate over-the-counter access for STENDRA®. The company is refining the app based on the initial study and is in continuous discussion with the FDA to align with their objectives.
STENDRA® (avanafil) is a prescription medication for erectile dysfunction and if approved for OTC access, could be the first in its class to achieve this status. The FDA's process for such a switch involves rigorous testing to ensure consumers can make informed decisions based solely on the information provided in the Drug Facts Label.
The press release also included important safety information about STENDRA® and a note on forward-looking statements, cautioning that actual results may differ from those projected. It concluded by providing contact information for investors and media inquiries.
This article is based on a press release statement from Petros Pharmaceuticals.
In other recent news, Petros Pharmaceuticals has announced significant developments regarding its erectile dysfunction drug, STENDRA® (avanafil). The company has reported encouraging results from a pivotal study, indicating a high correct self-selection rate when patients used the company's proprietary Web App Technology. The study, involving 509 subjects, showed a 94.9% correct self-selection rate, a marked improvement over the use of a Drug Facts Label alone.
Petros Pharmaceuticals is in discussions with the FDA, presenting these results as part of their efforts to gain approval for STENDRA® as an over-the-counter (OTC) medication. If successful, this move could potentially make STENDRA® the first drug in its class to be available without a prescription. This aligns with the FDA's Additional Conditions for Nonprescription Use (ACNU) program, which aims to expand OTC access to medications that previously required a prescription.
In addition to this, Petros Pharmaceuticals has entered into a partnership with telehealth provider Lemonaid Health, a subsidiary of 23andMe Holding Co. This collaboration aims to offer STENDRA® to a broader customer base, leveraging Lemonaid Health's nationwide telemedicine services. These are the recent developments in Petros Pharmaceuticals' ongoing efforts to increase consumer access to important medications.
InvestingPro Insights
Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) has shown promising results from its study on consumer comprehension of its App Technology for STENDRA®. As the company aims to transition STENDRA® to over-the-counter status, it's important for investors to consider the financial health and market performance of PTPI.
InvestingPro Data indicates a market capitalization of $3.33 million, underscoring the company's position in the market. Despite the positive news on their consumer study, PTPI's Price to Earnings (P/E) Ratio stands at -0.07, reflecting that the company is not currently profitable. This aligns with the InvestingPro Tip that analysts do not anticipate the company will be profitable this year. Additionally, the Price to Book (P/B) Ratio of 0.41 suggests that the market values the company at less than the net value of its assets, which could be interpreted as the stock being undervalued or that investors are not confident about the company's future growth.
An InvestingPro Tip worth noting is that PTPI operates with a moderate level of debt. While this may be a concern for some investors, it could also indicate that the company is investing in its growth, particularly in its efforts to bring STENDRA® over-the-counter.
Investors interested in PTPI's detailed performance metrics and additional insights can find more InvestingPro Tips at https://www.investing.com/pro/PTPI. With the company's ongoing FDA discussions and larger scale study on the horizon, these insights can help investors make informed decisions. There are a total of 8 additional InvestingPro Tips available for PTPI, providing a comprehensive analysis of the company's financial health and stock performance.
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