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Q&A: How healthcare is driving innovations in over-the-counter access

The regulations, which the FDA is currently finalizing, introduced Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers.

The proposed reforms are intended to make pharmaceutical drugs cheaper, prevent shortages and speed up delivery of new compounds
The proposed reforms are intended to make pharmaceutical drugs cheaper, prevent shortages and speed up delivery of new compounds - Copyright AFP/File Louisa GOULIAMAKI
The proposed reforms are intended to make pharmaceutical drugs cheaper, prevent shortages and speed up delivery of new compounds - Copyright AFP/File Louisa GOULIAMAKI

The healthcare market continues to expand, with new products and technologies coming online. An important component of this is with the prescription to over-the-counter self-care market.

To gain an insight with what companies are doing in this space, Digital Journal caught up with Fady Boctor, President and Chief Commercial Officer at Petros Pharmaceuticals (PTPI).

The company is currently developing and executing on a new pathway toward non-prescription or potentially over-the-counter access for its current lead product, STENDRA®. As part of Petros’ strategy, the company is utilizing new proposed FDA rules to safely bring mature Rx products to the market without the requirement of an authorized prescription.

Digital Journal: Can you provide a brief background on Petros Pharmaceuticals?

Fady Boctor: Petros Pharmaceuticals, which went public in December 2020, is a leader in the emerging prescription to over-the-counter (Rx-to-OTC) self-care market. We are developing a replicable technology-enabled process toward bringing mature Rx products OTC in conjunction with FDA guidelines. Currently, we are implementing this process for our lead erectile dysfunction (ED) therapeutic, which has the potential to be the first prescription-grade ED medication to be available OTC.

Additionally, we have a renowned Board of Directors team that includes the Founder and Principal of Juggernaut Capital Partners, John Shulman, and the President and CEO of Foundation Consumer Healthcare, Greg Bradley, among others. We are also proud to be well-funded to reach our short-term milestones and believe we are a true innovator within the pharmaceutical industry.

DJ: Petros is a key supplier in the emerging prescription to over-the-counter (Rx-to-OTC) market. What does this market look like and why do you think it’s an important area to focus on?

Boctor: The Rx-to-OTC market is growing rapidly and valued today – in 2023 – at $38.7 billion, and projected to grow to reach $66.5 billion by 2033, posting an estimated 5.6% CAGR, according to FMI’s Rx-to-OTC Switches Market. This market poses a new horizon of increased access of prescription grade pharmaceuticals accessible as OTC therapeutics, with innovative technology platforms that are designed to enhance appropriate consumer self-selection.

DJ: What role does self-care have in the Rx-to-OTC market?

Boctor: It is a major driver. The U.S. public sentiment has resounded a preference for self-care therapeutics, which includes critical pharmaceutical grade therapies. Consumers want to have greater control of their health and are looking for accessible therapies to meet their needs without needing to visit a doctor for a script. The FDA has acknowledged this and has established a path conducive for growth in this segment.

DJ: Petros has created a replicable process toward bringing mature products OTC in conjunction with FDA guidelines. Can you provide an overview of this process and how you are incorporating technology into it?

Boctor: The pathway first involves the design of a Drug Facts Label (DFL) that is well understood by potential consumers. Then data must demonstrate that they can make an appropriate decision to use or not to use the product based on the DFL and their personal medical history. Afterwards, the consumer must show that they can properly use the product based upon the information on the DFL. To accomplish these things, the FDA typically 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) showing safe and appropriate use by consumers in a simulated OTC setting.

The regulations, which the 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, a technology, or the additional conditions may use other approaches that support the switch process.

DJ: You are working on bringing your leading erectile dysfunction (ED) therapeutic, OTC. Where are you the process currently?

Boctor: The image [below] is a good visual of our progress. We are currently preparing for an upcoming SSS and further development of our technology platform. We recently completed a pivotal LCS (2nd iteration) and have conducted two SSS pilots. The most important components of the process to tune into the LCS, SSS and AUT. We are about halfway through our program.

Diagram of the Petros Pharmaceuticals manufacturing process. Image (C) Petros Pharmaceuticals, with permission.

What are some of the major trends you are seeing in the pharmaceutical industry? We are seeing a resurging interest in mature pharmaceutical therapies as they become viable OTC prospects. Many major players have begun to divest their consumer divisions to help accommodate this resurgence.

This includes Haleon (spun out from GSK), Kenvue (spun out from Johnson & Johnson), and a recent pure play focus announced by Perrigo. This is a major trend that will continue to influence the formation of this significant marketplace. Additionally, although still early, there are compelling signals observed that indicate future trends towards emerging technologies, such as AI and machine learning, to help support the advancement of the pharmaceutical industry.

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Written By

Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, business, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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