Petros Pharmaceuticals Forms Advisory Committee for STENDRA Rx-to-OTC Switch

Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company dedicated to broadening consumer access to medications through over-the-counter (OTC) drug development, has announced the formation of an Advisory Committee. This committee is set to provide valuable guidance as Petros prepares for the potential transition of STENDRA from prescription (Rx) to OTC status. This process will involve strategic interactions with the U.S. Food and Drug Administration (FDA).

Fady Boctor, President and Chief Commercial Officer of Petros, emphasized the significance of the Advisory Committee. He stated, "We believe this diverse team of subject matter experts, which includes former FDA officials, will be instrumental in helping to ensure our development program is pursued with the same anticipated rigor we expect to experience when presenting the program to regulators." Boctor highlighted the importance of aligning Petros's perspective with the FDA's guidance, noting the committee's value and synergy in FDA engagements since its inception.

The Advisory Committee consists of seven members, including industry-leading statisticians, clinical pharmacologists, and experts in cardiology and urology. This multidisciplinary team brings a wealth of experience from various sectors, including academia, industry, and government agencies. The committee aims to replicate the rigorous standards regularly employed by the FDA as Petros continues its development efforts for the Rx-to-OTC transition of STENDRA.

These experts will assist Petros in crafting a strategic approach that encompasses study protocols, subject recruitment, user-related risk analyses, and patient-centered considerations. The objective is to optimize care in a potential non-prescription setting, ensuring consumer safety and efficacy.

Petros Pharmaceuticals is committed to pioneering in the self-care market by driving expanded access to prescription pharmaceuticals as OTC treatment options. Currently, the company is focused on increasing access to its flagship erectile dysfunction (ED) therapy, STENDRA, through potential OTC designation. If approved by the FDA, STENDRA could become the first in its class to achieve this marketing status, establishing Petros's expertise as a platform for other prescription therapeutics.

The process of transitioning a prescription medication to OTC status involves several critical steps. Initially, a Drug Facts Label (DFL) must be designed to ensure potential consumers understand the product. Data must demonstrate that consumers can make informed decisions based on the DFL and their medical history. Additionally, consumers must show they can use the product correctly based on the DFL information. This process typically involves consumer-tested OTC DFLs, which include iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in interested and potentially at-risk populations, and usually one Actual Use Trial (AUT) demonstrating appropriate use in a simulated OTC setting.

The FDA is finalizing regulations that introduce Additional Conditions for Nonprescription Use (ACNU) criteria. These criteria enable correct self-selection by consumers and may broaden OTC access to medications previously available only by prescription. An ACNU might involve innovative computerized tools or other approaches that support the transition process.

In summary, Petros Pharmaceuticals, through its newly formed Advisory Committee and strategic planning, is making significant strides toward potentially transitioning STENDRA from prescription to over-the-counter status. This move aims to enhance consumer access to effective ED treatment while adhering to rigorous safety and efficacy standards.