Lauren Clason writes: Cadence OTC is planning to use the proposed pathway — once finalized — for its combination estrogen and progestin birth control pill Zena, following conversations with the FDA, company co-founder and co-CEO Samantha Miller said.
The company initially resisted the idea of requiring consumers to take an additional step before purchasing the pill, but ultimately began testing an online questionnaire designed to exclude those at higher risk of side effects.
“We and our experts believe we didn’t need it, and that we could have a well-performing, well-communicating label without it. And we did label development and testing for several years, and we did end up with a strong label that tested very well,” she said. “The FDA was not satisfied with it, and I think part of the reason they weren’t satisfied was that they had in their mind that this fit with this new approach.”
The combination pill has small but higher risks of serious side effects than progestin-only pills, including blood clots and stroke.
The vast majority of consumers who use birth control pills take the combination pill, which means Zena would likely appeal to a broad number of consumers even if Opill gets the green light.
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