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Petros Pharmaceuticals, Inc. ("Petros," or the "Company") (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces it has received positive feedback from the U.S. Food and Drug Administration (the "FDA," or the "Agency") following the FDA's informal review of Petros' technology component for self-selection as the Company endeavors to achieve OTC status for STENDRA. The Agency acknowledged that the technology addressed some of its concerns regarding the PDE5 inhibitor class in that context, particularly with regard to nitrate-using patients.
Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We view this meeting with the FDA as a significant step in our efforts to move STENDRA to OTC status, a move that would be the first among erectile dysfunction drug manufacturers. We found the FDA's feedback following our recent meeting to be encouraging, and we will incorporate it as we continue to move forward. We are grateful for the input from our internal advisory committee and subject matter experts and are confident that the incorporation of assistive technology has the potential to improve our process, resulting in better outcomes in our studies. We continue to believe OTC STENDRA presents a unique opportunity to treat a significant unmet medical need and look forward to further guidance from the Agency as we continue our development efforts."
During the recent Type C meeting between Petros and the FDA, the Agency also aligned with the Company in terms of its 2H 2024 submission and review of its pivotal two-arm Self-Selection study, which is currently underway. In addition, the Company received guidance from the FDA on its next technology-centered study, the Application Comprehension Study, which will be subsequently announced following additional steps being completed.
About the OTC Pathway
The process of switching a prescription medication to over the counter (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 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 these things, the FDA ordinarily requires a consumer tested OTC DFL. This 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.
Posted In: PTPI
