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# FDA Offers Path Forward for Twirla NDA
- URL: https://www.fdaweb.com/fda-offers-path-forward-for-twirla-nda/
- Published: 2018-10-09T12:00:00.000Z
- Updated: 2026-09-15T00:36:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142547

Although it denied an Agile Therapeutics formal dispute resolution request involving a decision by the CDER Division of Bone, Reproductive, and Urological Products (DBRUP) that Agile’s Twirla could not be approved due to concerns about its *in vivo* adhesion properties, the CDER Office of New Drugs (OND) proposed a path forward for the company without having to reformulate Twirla or conduct a bioequivalence study between formulations. Twirla (levonorgestrel/ethinyl estradiol transdermal system) is described as an investigational low-dose, once-weekly contraceptive patch. A 12/21/17 complete response letter said Twirla could not be approved in its present form due to deficiencies related to quality adhesion test methods, observations identified during a pre-approval inspection at the product’s manufacturing facility, and because of adhesion property questions.

OND suggested that Agile conduct a wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane, the generic version of the previously marketed Ortho Evra contraceptive patch. OND recommended that the company meet with DBRUP staff to get agreement on the specific design and success criteria of a wear study.

“We appreciate the constructive discussions we’ve had with FDA during this formal dispute resolution process,” Agile CEO **Al Atomari** said. “We are pleased that OND has provided a path forward and we plan to meet with the division to discuss the specifics of the proposed wear study as soon as possible.”