Agile Therapeutics Provides Regulatory Update and Reiterates Cash Guidance

Agile Therapeutics (Nasdaq:AGRX), a women’s healthcare company, announced that on January 9, 2019 it received final meeting minutes from its December 11, 2018 meeting with the U.S. Food and Drug Administration’s Division of Bone, Reproductive, and Urologic Products.

As quoted in the press release:

In its meeting with DBRUP, the Company discussed the specific design and success criteria of the comparative wear study, which is intended to demonstrate adequate adhesion via non-inferiority of Twirla to Xulane, the generic version of the previously marketed Ortho Evra^® contraceptive patch, a product the FDA considers to have acceptable adhesion.  After consultation with DBRUP, the Company has initiated a crossover wear study in approximately 80 healthy women with a Body Mass Index of less than 35 kg/m² who will be randomized to wear either Twirla or Xulane for the first week and then switched to the patch not initially worn for the second week. The overall design of this comparative wear study follows the FDA’s guidance with respect to abbreviated new drug applications, entitled Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.

“Now that we have completed our discussions with the FDA, we are eager to complete the comparative wear study and resubmit our Twirla new drug application (“NDA”).  I can confirm, as we previously stated, that we expect to complete the study in the first quarter of 2019 and to resubmit our NDA in the first half of 2019, which gives us the opportunity to receive approval by the end of 2019,” said Al Altomari, Chairman and Chief Executive Officer of Agile Therapeutics, Inc.

Click here to read the full press release.