Petros Pharmaceuticals Seeks to Disrupt the Prescription Erectile Dysfunction (ED) Market
Fady Boctor, President and Chief Commercial Officer of Petros Pharmaceuticals
Petros Pharmaceuticals (NASDAQ: PTPI) seeks over-the-counter (OTC) designation for its prescription — FDA-approved and patent-protected — erectile dysfunction (ED) medication, a component of Petro’s objective to address availability, stigma and other access barriers in this underserved market.
For most men with ED, getting prescription therapy can be an ego-bruising journey. It is estimated that approximately 75% of men with the dysfunction in the United States have not received prescription therapy.
Petros Pharmaceuticals will seek FDA guidance, and approval, to introduce the first prescription ED therapy available OTC, potentially pioneering a new frontier of access for this significant marketplace.
Prevalence
According to an article published in Current Opinion in Nephrology and Hypertension, the overall prevalence of ED is estimated to affect 150 million men worldwide, with 30 million sufferers in the U.S. alone. The article also estimates that approximately 322 million men worldwide will suffer from the condition by 2025.
Stigma
Fady Boctor, President and Chief Commercial Officer of Petros Pharmaceuticals, pointed out in an exclusive interview with Benzinga that most men with ED have not purchased or used any of the drugs on the market in part because of the stigma and embarrassment associated with the condition.
"Prescription medicine, such as Viagra and Cialis, for example, has been around now for almost 20 years. For the two decades that these prescription products have been on the market, only 25% of the 30 million men suffering from ED are estimated to have actually received a prescription, which means we're potentially looking at nearly three-quarters or 75% that remain untreated," he said.
If approved by the FDA, OTC availability of the medication may make it possible for men concerned about the stigma to simply walk into their local pharmacy and discreetly pick up a prescription as they would potentially buy Advil or Tylenol.
In addition to the privacy gained by obtaining medicine over the counter, patients can order the medication online without a physician's engagement. "So that's one of the ways we look to create greater access, and we think we have the right product to help us get there," Boctor said.
The OTC Pathway
The FDA requires a draft OTC label that communicates a product's instructions for use, warnings and cautions at a low health literacy level. In addition, there are three core trials required: a Label Comprehension study, a Self-Selection study, and an Actual Use study. Depending on their evaluation, additional steps may be required by the FDA. All are intended to demonstrate safe and appropriate consumer use and self-selection. Petros launched this process in Q1 2021 and has developed an initial draft of an OTC label, conducted an initial pilot Label Comprehension Study and is preparing to launch a Phase II Label Comprehension Study in the coming weeks.
Device Portfolio
Petros Pharmaceuticals also has a device portfolio for erectile therapy. The devices, which have several accessories such as constriction rings, are vacuum erection systems where blood is infused into the penis by a pump as medical-grade therapy.
Portfolio Prospect – Peyronie's Disease
Petros Pharmaceuticals has expanded its portfolio by licensing a novel, topical formulation for the treatment of acute Peyronie's disease (PD), which has demonstrated positive results in a small pilot/concept study. Petros plans to meet with the FDA for a clinical development roadmap in the coming months.
The product, H100, if approved by the FDA, would be the first and only clinically demonstrated topical, noninvasive treatment for acute PD — a landmark achievement in men's health.
The product, Boctor noted, "if approved by the FDA, will significantly impact men in addressing this devastating penile fibrotic condition, with a noninvasive therapeutic. That is something that we are proud to be a part of and we think will be another potential landmark achievement. We hope to continue that tradition in the areas where men are suffering silently with a lack of therapeutic options."
About Petros Pharmaceuticals
Petros Pharmaceuticals was founded upon its first and currently commercialized Men's Health therapeutic, a distinct molecule in ED, with an aim to continue awareness, education, and therapeutic value to the men's sexual dysfunction landscape.
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