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Petros Pharmaceuticals Executive Discusses Wider Availability of Oral Contraceptive


In an interview with Pharm Exec Associate Editor Don Tracy, Fady Boctor, President, Chief Commercial Officer, Petros Pharmaceuticals talks about the recent availability of Opill as an over-the-counter (OTC) contraceptive.

PE: For our audience, can you tell us what the wider availability of Opill could mean for the future of the contraceptive market?

Boctor: It's an amazing gateway. I think that this has been a product line that has been anticipated for over-the-counter access for some time. So the fact that it's been passed today demonstrates that the FDA is beginning to expand their appetite and allowance for critical therapeutics to be available over the counter. This is the first among many in its class. The next step is the combination or contraception product model. This is a nice gateway into female contraception. But we think it opens the gates for what many wouldn't have anticipated a reality, which should be on its way shortly.

PE: Can you explain the process behind taking a product from Rx-to-OTC? What do you think were the biggest benefits as well as challenges?

Boctor: You're dealing with products that are relatively seasoned and mature in the marketplace. But they've been well studied clinically and approved by the FDA, and in many cases, they have millions of patients that have already undergone and experienced it. So with that, the switch from prescription over the counter becomes more of a comprehension and behavior process. You have to demonstrate to the FDA that these products will be safely used, safely selected, the labor will be comprehended, and consumers will not only self diagnose, but self appropriate. There's labor comprehensive studies, one of the studies that have to be conducted, self selection studies, and actual use studies. Two of them are comprehension and behavior, and the last examines selection. It's a bit of a different development plan than clinical development. There have only been 106 sine 1976. It says that these products are carefully looked at. We still haven't gotten into a high volume of transitions and switches yet, and that time is coming. In terms of the biggest benefits so far, appoint everybody to consumer health care products of association with HPA. They're critical because they've been watching and tracking this. They're advocates of these developments in the switches. According to the Consumer Healthcare Products Association, they saw an increase in utilization from 66 to 75% in the antihistamines and allergy spaces just by becoming more available over-the-counter. Perhaps one of the biggest markets of switch that demonstrate the value is smoking cessation with nicotine cessation patches. It shows that Americans sometimes confront stigma. They don't always want to have conversations about it. If you educate them to make it available to them, they would far more prefer the ability to go pick it up at the local pharmacy or purchase it online without any human interaction. We're just unique that way.

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