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# Agile to Pursue Twirla FDA Appeal
- URL: https://www.fdaweb.com/agile-to-pursue-twirla-fda-appeal/
- Published: 2018-07-25T12:00:00.000Z
- Updated: 2026-09-15T00:21:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141960

Agile Therapeutics says it will appeal to the CDER Office of New Drugs the decision by the Office of Drug Evaluation 3 (ODE3) director to deny its appeal of a Division of Bone, Reproductive, and Urologic Products complete response letter for its NDA for Twirla (levonorgestrel/ethinyl/estradiol transdermal system) that cited concerns about the product’s *in vivo* adhesion properties.

Twirla is described as an investigational low-dose once-weekly contraceptive patch.

Agile initiated formal dispute resolution with ODE3 on 6/6 to appeal the 12/21/17 complete response letter. Company officials say they continue to believe that the Phase 3 SECURE trial yielded *in vivo* adhesion data that are adequate for Twirla’s approval and did not affect clinical outcomes.