Oral Contraceptive OTC Proposal Moves Closer With Start Of Actual Use Study
This article was originally published in The Pink Sheet & The Rose Sheet
HRA Pharma started recruiting in April for an actual use trial, using oral contraceptives with norgestrel 0.075 mg, and expects to complete its study in April 2019, according to clinicaltrials.gov's database. Advocacy group Ibis Reproductive Health, which is working with HRA on an NDA for an OTC oral contraceptive, called the start of the study a "pivotal moment" in moving birth control drugs out of Rx-only.
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Perrigo is the top potential marketer of the first OTC oral contraceptive in the US by acquiring HRA Pharma, which is preparing a switch NDA and earlier in 2021 gained UK regulatory approval for pharmacy sales of a progestin-only contraceptive, desogestrel.
HRA brings needed expertise in OTC switches to Perrigo, which regularly is first to launch generic equivalents for brand switches but its name hasn’t been linked to submitting proposals for making additional drug ingredients available OTC.
Nearly 120 researchers, clinicians and advocacy groups have signed a letter to be sent in late August urging FDA to prioritize completion of a review process to make oral contraceptives available OTC.