Agile Therapeutics, Inc. Meets Division of Bone, Reproductive, and Urologic Products to Discuss the Design of Comparative Wear Study Between Twirla and Xulane
January 10, 2019 at 09:15 pm
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Agile Therapeutics, Inc. 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. The Company met with DBRUP to discuss the design of a comparative wear study between Twirla® and Xulane® as suggested by FDA’s Office of New Drugs in its decision on the Company’s previously announced formal dispute resolution request. 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. The Company also expects that the FDA will conduct a pre-approval inspection of the Company’s third-party manufacturer’s facility, which must be successfully completed prior to approval.
Agile Therapeutics, Inc. is a women's healthcare company, which is engaged in fulfilling the unmet health needs of women. Its product and product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method. Its initial product, Twirla, (levonorgestrel and ethinyl estradiol), a transdermal system, is a non-daily prescription contraceptive. Twirla is based on its proprietary transdermal patch technology, called Skinfusion, which is designed to allow drug delivery through the skin. Twirla (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestin, and ethinyl estradiol (EE), a type of estrogen. Its potential product pipeline consists of two types of product candidates: a progestin-only (P-only) contraceptive patch and potential Twirla line extensions.
Agile Therapeutics, Inc. Meets Division of Bone, Reproductive, and Urologic Products to Discuss the Design of Comparative Wear Study Between Twirla and Xulane