Petros Pharma is focused on establishing mechanisms for Rx-to-OTC switch: CCO Fady Boctor

Petros Pharmaceuticals, Inc. (NASDAQ: PTPI) is a pharma company focused on identifying, developing, and commercializing therapeutics for men’s health issues. It operates mainly through the business segments of Prescription Medications and Medical Devices. Currently, the company is engaged in the commercialization and development of Stendra, an FDA-approved PDE-5 inhibitor prescription medication for the treatment of ED.

In an email conversation with AlphaStreet, the company’s president and chief commercial officer Fady Boctor spoke about the challenges and opportunities for the business.

Please give a brief overview of the company and its operations

Petros Pharmaceuticals is committed to becoming a leading innovator in the emerging self-care market by driving expanded access to key prescription pharmaceuticals such as over-the-counter (OTC) or nonprescription treatment options. Currently, Petros is pursuing increased access for its flagship prescription erectile dysfunction (ED) therapy, STENDRA, for potential OTC or nonprescription designation.

What differentiates Petros Pharmaceuticals from other pharma companies?

Petros is a lean, efficient, and hyper-focused organization with the only patent-protected prescription ED medication available on the market, STENDRA (in the same class of medication as Viagra and Cialis). This enables the company’s prospects to become a potential first mover, as the first company to potentially introduce the first-ever prescription-grade pharmaceutical as a non-prescription or OTC treatment option. The know-how and associated methods, including customized technology solutions, may be applicable to other Rx products currently in the market that stand to reach more patient consumers without a prescription or as an OTC treatment option.

What are the key challenges and opportunities for the company in the men’s health market?

In a recent announcement, we have emphasized our focus on establishing innovative mechanisms for switching products from Rx to non-Rx designation (OTC), essentially competitively participating in the emerging self-care market, with STENDRA as a possible initial debut. Therefore, challenges will predominantly center around future study results and regulatory authority decision-making by the FDA. Opportunities are significant, as the emerging self-care market continues to grow and the Rx-to-OTC switch market within it produces approximately $39 billion in 2023 and is estimated to grow to $67 billion by 2033, according to Future Market Insight’s Rx-to-OTC Switch Outlook.  

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Can you provide insights into the current clinical trials, including their expected outcomes and timeline?

The process of switching a prescription medication to OTC involves the design of a clear-to-layman, shelf-friendly medication label, demonstrated comprehension of key safety parameters, and proven appropriate consumer self-selection. The FDA ordinarily requires a consumer-tested OTC Drug Facts label (DFL), Label Comprehension Studies (LCS), Self-Selection Studies (SSS), and at least one Actual Use Trial (AUT) demonstrating safe and appropriate non-practitioner-guided, yet consumer-led use. Recently, a communication by the FDA introduced Additional Conditions for Non-prescription Use (ACNU) criteria that may expand OTC access to several prescription medications and enable innovative tools to help support the switching process.

Petros has produced several iterations of an OTC DFL, completed several studies evaluating comprehension of the DFL (both pivotal LCS and pilot SSS), and is now working with the FDA to establish the next steps estimated to include a pivotal SSS scheduled to launch by end of 2023. Often powered by a 95% Confidence Interval, the study protocols generally include several primary endpoints designed to evaluate the consumer’s understanding of particular use cases and/or self-determination of appropriate use with individual item target thresholds often greater than 90% comprehension or appropriate self-selection respectively.

What is your strategy for expanding the portfolio and pipeline, against the backdrop of giving non-prescription status to STENDRA?

Currently, the strategy is focused on developing solutions for the Rx-to-OTC or nonprescription switch of STENDRA. However, future target conditions for use may conceivably include other common Primary Care conditions or common reasons for Primary Care visits also known as common RFVs, possibly including mild-to-moderate cases of UTIs, hypertension, arthritis, diabetes, depression, anxiety, pneumonia, otitis media, back pain, and dermatitis as early concepts of interest. There is much to accomplish with the current task at hand in developing STENDRA as a nonprescription treatment option, in collaboration and under the authority of the FDA. However, today’s developments may have significant implications for tomorrow’s therapeutic candidates.