Fady Boctor, President and Commercial Director of Petros Pharmaceuticals
Petros Pharmaceuticals (NASDAQ: PTPI) seeks over-the-counter (OTC) designation for its prescription drug – FDA-approved and patent-protected – for erectile dysfunction (ED), a component of Petro’s goal to fight against availability, stigma and other barriers to access in this underserved market.
For most men with erectile dysfunction, getting prescription treatment can be a painful journey for the ego. It is estimated that about 75% of men with dysfunction in the United States have not received prescription treatment.
Petros Pharmaceuticals will seek guidance and approval from the FDA to introduce the first over-the-counter prescription ED treatment, which could pave the way for a new frontier of access for this important market.
According to an article published in Current opinion in nephrology and hypertension, the global prevalence of erectile dysfunction is estimated to affect 150 million men worldwide, including 30 million in the United States alone. The article also estimates that approximately 322 million men worldwide will suffer from the disease by 2025.
Fady Boctor, President and Chief Commercial Officer of Petros Pharmaceuticals, pointed out in an exclusive interview with Benzinga that most men with erectile dysfunction 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 drugs, such as Viagra and Cialis, for example, have been around for almost 20 years. In the two decades that these prescription products have been on the market, it is estimated that only 25% of the 30 million men with erectile dysfunction have actually received a prescription, which means that we are potentially looking at close to three-quarters or 75 % that remain untreated, ”he said.
If approved by the FDA, the availability of the over-the-counter drug may allow men concerned about the stigma to simply go to their local pharmacy and discreetly take a prescription as they would potentially purchase Advil or Tylenol.
In addition to the privacy gained by obtaining over-the-counter drugs, patients can order the drugs online without the commitment of a physician. “So that’s one of the ways we’re looking to create better access, and we think we’ve got the right product to help us achieve that,” Boctor said.
The OTC way
The FDA requires a draft OTC label that communicates instructions for use, warnings, and cautions for a product at a low level of health knowledge. In addition, three main tests are required: a label comprehension study, a self-selection study, and an actual use study. Depending on their assessment, 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 the first quarter of 2021 and has developed a first draft of an OTC label, has conducted a first pilot label understanding study and is preparing to launch a phase II label comprehension study in the coming weeks. .
Petros Pharmaceuticals also has a portfolio of devices for erectile therapy. The devices, which have several attachments 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 new topical formulation for the treatment of acute Peyronie’s disease (PD), which has shown positive results in a small pilot / design 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 non-invasive topical treatment for acute PD – a landmark achievement in men’s health.
The product, Boctor noted, “if approved by the FDA, will have a significant impact on men in the treatment of this devastating penile fibrotic disease, with non-invasive therapy. This is something we are proud of. be a part and we believe this will be another potential landmark achievement.We hope to continue this tradition in areas where men silently suffer from a lack of treatment options.
About Petros Pharmaceuticals
Petros Pharmaceuticals was founded on its first, currently commercialized men’s health therapeutic product, a separate erectile dysfunction molecule, with the goal of further raising awareness, education and therapeutic value of the male sexual dysfunction landscape.
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