Agile Therapeutics Inc. said the U.S. Food and Drug Administration has asked the company to conduct a so-called wear study before it can accept its contraceptive patch Twirla for review.
The FDA's Office of New Drugs wants the company to demonstrate that Twirla has the same adhesive properties as Mylan NV's Xulane patch, which the regulator considers to have acceptable adhesion.
The company plans to meet with officials and finalize the design of the suggested study before resubmitting another application for Twirla.
Agile's contraceptive patch was rejected by the U.S. regulator for a second time in December 2017 over adhesion and manufacturing concerns. The second submission was supported by data from a phase 3 trial addressing issues raised by the FDA in 2013.
The Princeton, N.J.-based women's healthcare company appealed against the decision, which was denied by the FDA's Division of Bone, Reproductive and Urological Products.
Even though the appeal was denied, the Office of New Drugs provided a path forward via a formal dispute resolution process that does not require the company to reformulate Twirla or conduct a bioequivalence study between formulations as previously suggested by the FDA's Division of Bone, Reproductive and Urological Products.