PRGO - Perrigo down ~4% on FDA briefing docs on OTC birth control pill

2023-05-05 13:09:41 ET

Perrigo ( NYSE: PRGO ) is down ~4% in Friday afternoon trading as US FDA scientists expressed concerns over the company's application to have the birth control pill Opill (norgestrel) available over the counter.

Specifically, agency reviewers noted that the increasing rates of obesity in the U.S. could impact the drug's efficacy. They added that Perrigo ( PRGO ) didn't provide any additional information as to how this would be addressed without a doctor's involvement.

The Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee will meet on May 9 and 10 to discuss Perrigo's ( PRGO ) application.

Although Opill, marketed by Perrigo ( PRGO ) division HRA Pharma, has been available since the 1970s, it could become the first daily birth control pill to be available without a prescription.

"Given that this product was approved in the 1970s and the paucity of data in today's target population of reproductive females in the United States, real-world effectiveness of this product in the United States remains ill-defined," the reviewers wrote.

The briefing document notes that in 1960, the obesity rate was 13%. In 2021, it grew to 42%.

"The degree to which efficacy of norgestrel tablet is diminished in individuals who are overweight or obese...remains unknown," the document reads. "Neither Study 002 nor ACCESS provide additional insight into norgestrel's magnitude of contraceptive efficacy in the population likely to use the product in a nonprescription setting."

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