Agile Therapeutics provides regulatory update, reaffirms cash guidance
Agile Therapeutics 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 FDA has previously informed the company that in connection with its review of the Twirla NDA, the FDA plans to bring the safety and efficacy of Twirla to an Advisory Committee. 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. The company believes that its unaudited cash and cash equivalents as of December 31, 2018, will be sufficient to meet its projected operating requirements into the second quarter of 2019, which will include completion of the comparative wear study. The company will require additional capital to fund operating needs for the remainder of the second quarter of 2019 and beyond, including among other items, preparation for an anticipated Advisory Committee meeting to discuss safety and efficacy of Twirla, the completion of its commercial plan for Twirla, which primarily includes validation of the commercial manufacturing process and the commercial launch of Twirla, if approved, and advancing the development of its other potential product candidates.