NEW YORK - Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company specializing in making prescription medications more accessible through over-the-counter (OTC) options, reported receiving encouraging feedback from the U.S. Food and Drug Administration (FDA) regarding its erectile dysfunction drug, STENDRA. The feedback came after an informal review of Petros' technology for self-selection aimed at securing OTC status for the drug.
The FDA's response to the technology component, according to the company, has addressed some concerns related to the PDE5 inhibitor class, particularly for patients using nitrates. Petros' President and Chief Commercial Officer, Fady Boctor, expressed optimism about the progress, stating that the FDA's input is a significant milestone in their efforts to transition STENDRA to OTC status, potentially making it the first erectile dysfunction drug with such designation.
The recent Type C meeting between Petros and the FDA also resulted in alignment on the company's plans for submitting and reviewing its pivotal two-arm Self-Selection study in the second half of 2024. Additionally, the FDA provided guidance on the upcoming technology-centered Application Comprehension Study, details of which are to be announced after further steps are completed.
The OTC pathway involves demonstrating through studies that consumers can understand the Drug Facts Label (DFL), make appropriate decisions based on the DFL and their medical history, and correctly use the product. The FDA's emerging Additional Conditions for Nonprescription Use (ACNU) criteria may facilitate the transition of certain prescription medications to OTC by ensuring proper self-selection by consumers, potentially through innovative tools.
STENDRA (avanafil), initially launched by Auxilium Pharmaceuticals and later acquired by Endo Pharmaceuticals, is a PDE5 inhibitor for erectile dysfunction treatment. It is not intended for women or children and comes with specific safety information, including contraindications for patients using organic nitrates or with certain cardiovascular conditions.
This report is based on a press release statement from Petros Pharmaceuticals.
InvestingPro Insights
As Petros Pharmaceuticals (NASDAQ:PTPI) endeavors to make erectile dysfunction medication STENDRA available over-the-counter, investors are closely monitoring the company's financial health and stock performance. Here are some insights based on real-time data from InvestingPro that may be relevant for stakeholders:
InvestingPro Data indicates a market capitalization of $5.38 million USD, reflecting the company's current valuation in the market. Despite the potential market expansion through OTC sales of STENDRA, Petros Pharmaceuticals has reported a revenue of $5.82 million USD for the last twelve months as of Q4 2023, with a concerning revenue growth rate of -2.83%. This contraction in revenue is further accentuated by a quarterly revenue decline of -145.64% in Q4 2023.
The company's financials also show a negative operating income margin of -184.84% for the same period, indicating that operating expenses have far exceeded the gross profit of $4.19 million USD. These metrics suggest that the company is facing significant challenges in achieving profitability.
In terms of stock performance, InvestingPro Tips highlight that PTPI's stock price has experienced considerable volatility and is currently trading near its 52-week low. The stock has also declined by -79.71% over the last year as of April 2024, and the recent one-month price total return stands at -38.73%. This underscores the stock's underperformance in the recent past.
Moreover, the Relative Strength Index (RSI) suggests that the stock is in oversold territory, which could indicate a potential turning point for investors looking for entry points, although the company's financials should be considered carefully before making investment decisions.
For those looking for a comprehensive analysis, InvestingPro offers additional tips on PTPI, including insights into the company's cash and debt position, valuation multiples, and profitability outlook. Interested readers can find more details and a total of 10 InvestingPro Tips by visiting https://www.investing.com/pro/PTPI. Furthermore, new subscribers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing even more value to those seeking in-depth financial analysis.
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