Cadence Health Inc.’s work on proposing an OTC daily oral contraceptive in the US continues somewhat in the shadow of a new drug application another firm submitted for the first birth control pill to be available nonprescription in the US.

Co-founder and co-CEO Samantha Miller told HBW Insight that the “public benefit start-up company” in Oakland, CA, realizes little has been reported about its work on its drug branded Zena compared to HRA Pharma’s NDA, prepared in collaboration with Ibis Reproductive Health advocacy group, submitted to the Food and Drug Administration in July.

“We have been quietly working behind the scenes for more than six years with the FDA on the long process for this first-in-class Rx-to-OTC switch,” Miller said.

Cadence’s progress on preparing an NDA for OTC sales of a combination-ingredient formulation – levonorgestrel 0.1 mg and ethinyl estradiol 0.02mg – was slowed in early 2021 when the FDA stated concerns that labels used in the firm’s label comprehension studies should include warnings about blood pressure risks.

“We have made some changes to our labeling based on extensive FDA feedback and we are re-conducting pivotal studies,” Miller said. Cadence hasn’t started an actual use trial for the formulation and isn’t saying when it expects it will or when it could submit an NDA to the FDA for OTC Zena.

As Miller noted, the American Medical Association earlier in 2022 recommended to the FDA that it allow OTC sales of birth control pills. (Also see "AMA Shares OTC Birth Control Diagnosis With FDA" - HBW Insight, 16 June, 2022.)

Other medical professional organizations supporting OTC access include the American College of Obstetricians and Gynecologists; American Association of Family Physicians; American College of Clinical Pharmacists; and American Public Health Association.

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