Issue:April 2024

EXECUTIVE INTERVIEW - Petros Pharmaceuticals & Self-Care: Expanding Access to Rx Products Through a Tech-Powered OTC Pathway

Petros Pharmaceuticals is focused on expanding consumer access to medication through over-the-counter (OTC) drug development programs. The company is in the process of bringing its current lead prescription (Rx) erectile dysfunction (ED) therapeutic OTC while developing a pathway that would take future therapeutics OTC as well. Petros is a pure play in the Rx-to-OTC self-care market, which is rapidly growing, and has a mission to empower patients to take better control of their health.

 Drug Development & Delivery recently interviewed Fady Boctor, President and Chief Commercial Officer at Petros Pharmaceuticals, to discuss the process of taking a product from Rx-to-OTC, the benefits and challenges of the process, and the future of the marketplace.

Q: Can you give an overview of how medications go from Rx-to-OTC?

A: It predominantly becomes a process of comprehension and the consumer behavior associated with it. Those are the core principles. There are three distinct studies that need to be completed, which have to do with comprehension, self-selection behavior, and actual use without a prescription. The first is a Label Comprehension Study, which once completed, allows companies to improve and enhance a label that is ultimately well understood by the laymen consumer.

Next is the Self-Selection Study, which brings that new and optimized label to men and women (also known as all-comers) and allows them to review the label and select whether or not to use the product. The study is reviewed to see whether the participants appropriately self-selected based on gender, medical disposition, and history. The comprehension becomes behavioral in this step.

The last study is the Actual Use Study/Actual Use Trial, which is akin to a Phase 3 clinical trial. The participants read the label, self-select, and use the product in a simulated OTC setting. This is the most expensive portion of the pathway and requires approval or pre-clearance by the FDA to conduct.

Along this pathway, there are numerous iterations to optimize the steps. And recently, there is a new frontier with technology and devices emerging, hence the FDA introducing and proposing Additional Conditions for Nonprescription Use (ACNU), which will enable companies to offer various resources (among them technology assistive tools such as apps) enhancing the appropriate and safe use of their Rx-to-OTC switch candidate. With these additional tools will come the necessity to conduct Human Factor Studies, assessing whether the consumer is able to navigate the app as intended.

Currently, the default for bringing a product OTC does not necessitate any additional tools, unless proven necessary. Only after a company shows the study participants have failed to comprehend and/or comply with a label is technology introduced.

For those who may be familiar with Risk Evaluation and Mitigation Strategy for prescription medications, also known as REMS, ACNU may be considered akin for certain Rx-to-OTC switches to come. This would potentially establish a new corridor for prescription to OTC switches in the future.

Q: What are the benefits of a product going from an Rx to an OTC availability?

A: The most pronounced benefit is expanded access enabling more people to use a particular therapy. The hurdles and burdens of having to make a doctor’s appointment and go to the appointment (whether in-person or virtually) are removed when a product goes OTC. The Consumer Healthcare Products Association (CHPA) is an advocate in this area and one of their case studies focuses on smoking cessation products. The utility of those products was somewhat meek when they were Rx. However, once they were switched to OTC, there was a 150%-200% increase in use during the first year of their switch. This impacted overall healthcare costs significantly, as smokers attempted to quit smoking, and whether they completely stopped or reduced their use, their outcomes were improved.

Another benefit is the potential for greater education. Taking a product OTC allows companies to educate a patient about the broader implications and progression of their condition. For example, a gentleman might not know that he has a serious heart issue if he is experiencing ED, and reading about it on a label or learning more via a web app during purchase may help enlighten him to seek appropriate evaluation and treatment.

Self-care is a growing market and having products available OTC empowers consumers.

Q: What is the market for Rx-to-OTC products? Can you provide examples of successful transitions?

A: The Rx-to-OTC switches market is rapidly growing. In 2023, it had a valuation of $38.7 billion, according to FMI’s Rx-to-OTC Switches Market Outlook. The report projects that this market will reach $66.5 billion by 2033.

There are many examples of successful Rx-to-OTC transitions. Some notable ones in 2023 were Opill, a birth control pill, and Narcan, a naloxone hydrochloride treatment for known or suspected opioid overdose. Others within the past 20 years include Nexium 24 HR, Flonase Allergy Relief, Zyrtec, Plan B, and Prilosec OTC. Additional ones can be found on CHPA’s Rx-to-OTC Switch List website.

Q: What is significant about Petros’ lead ED therapeutic going OTC?

A: It is important to note there are currently no clinical comparative data among the class of phosphodiesterase 5 Inhibitors (PDE5Is). Petros’ lead ED therapeutic hosts a distinct label, specific to its clinical trials, which also remains branded and patent-protected, encouraging ongoing development and investment, making it worth our company’s time. We are the New Drug Application (NDA) holder, and it is an added benefit we are taking the product OTC with the NDA in our possession.

Lastly, we believe the consumer education component is very important for any product that switches to OTC. There is an opportunity here to educate consumers and their advocates around broader health implications, awareness, and potential concerns. We intend to leverage our emerging OTC technology platform to help people learn more about their potential health issue and possible correlated comorbidities with actionable follow-up suggestions, while purchasing or engaging with their OTC therapy of interest.

Q: Can you discuss your process for taking the product OTC?

A: We are following the previously mentioned protocol. Additionally, we’ve developed our own scientific advisory committee. In many respects, they act and serve as an internal arms-reach FDA representation. The committee gives us the FDA perspective from a legal, regulatory, and clinical perspective. We have found this to be very productive and contributory and have had the committee attend many of our FDA meetings. We are not moving along the OTC pathway in a vacuum but are garnering guidance from this committee.

Our process also goes beyond a technology assistive tool, which we believe is a baseline feature. We are attempting to go beyond by seeking to integrate elements of AI addressing specific concerns that the FDA has communicated to us quite consistently. These include validating the patient, ensuring they are male, and that they are 18+ with ED.

We believe both of these – a scientific advisory committee and the use of AI to address FDA concerns – are emerging best practices.

Q: What are the greatest hurdles in switching a product from Rx-to-OTC?

A: We have identified three hurdles. First, the FDA is the greatest hurdle. However, I want to note what they do is necessary. They pressure test us and seek to answer critical questions of safety, especially around the anomalies. The greatest limiting factor is making sure we address their concerns, while forging ahead on a reliable and credible path forward. And even with a solid plan, there could be a shift in the plan/ideology at times, which could delay and require duplicative work. This is the second hurdle and is always on every sponsor’s mind.

The third biggest hurdle is budgetary constraints. It is important to be well-funded to do the quality work that needs to be done, and to appropriately use the funds accordingly.

Q: Where do you see the Rx-to-OTC market in the next 10 years?

A: Exciting things will happen in the next 10 years. As we see from the FMI statistic, the Rx-to-OTC market is set to nearly double throughout the next 10 years. We can see uncomplicated blood pressure medications, anti-depressants, single-dose antibiotics for uncomplicated urinary tract infections, statins, etc. possibly becoming available without a prescription. If somebody has consistent high blood pressure, for example, and begins to use an OTC treatment option, it may have a positive impact and ultimately a tremendous value to public health. Likewise, pre-diabetes and low-/early-stage diabetes products may also become OTC candidates. Combination oral contraception may become available – we believe Opill is just the beginning.

All of these will reduce US healthcare costs, increase proactive engagement with the healthcare landscape by the patient-consumer, and provide for an empowered self-care culture driven by US patient-consumer. Many of these conditions are reasons for common visits to primary care facilities, which are often schedule-prohibitive resulting in significant hurdles and delays in treatment. This Rx-to-OTC self-care landscape may help reduce a variety of bottlenecks and burdens in the healthcare system.

Q: Do you believe more products will go directly OTC when they are being developed?

A: If the prescription OTC space matures well enough, and there is a strong American awareness of general primary care and therapeutics available OTC, then I believe sponsors will prefer OTC vs. Rx.

There are a lot of complexities with developing new prescriptions. Sponsors of prescription therapies will often market to physicians, partner/contract with insurance companies/Pharmacy Benefit Managers (PBMs), attend practitioner conferences, utilize a large sales force, often issue coupon and voucher programs, as well as market directly to the patient-consumer (DTC); this is a remarkably costly investment.

By going OTC, sponsors of prescription-grade therapeutics may educate physician and consumers, but they do not need to partner with PBMs, and they do not need to offer coupons as long as their price is competitive. They can focus on treatment education, collaborate with pharmacies and distribution channels, and meet the patient-consumer in the same aisle and/ or web landing page as their preferred shopping channels.

Launching a product OTC makes for a far more controllable, streamlined, and convenient process, which is attractive to sponsors and patient-consumers alike. And with the growth of the self-care market, companies may be more focused on going direct-to-consumer versus building an entire infrastructure to take their Rx products OTC.