Agile Therapeutics Inc (NASDAQ:AGRX) announced Friday it has resubmitted to the US Food and Drug Administration a new drug application for its lead product Twirla, a low-dose prescription contraceptive patch.
The Princeton, New Jersey-based women’s health-care company had originally resubmitted an application for FDA approval in June 2017. Agile said the new application is intended to satisfy a complete response letter the regulator sent Agile, questioning the manufacturing process at a third-party facility and the adhesion properties of it proprietary patch technology called Skinfusion, among other issues.
In a statement, Agile said its resubmitted application also includes the comprehensive results from a comparative wear study (Twirla vs. Xulane, produced by Mylan Pharmaceuticals Inc (NASDAQ:MYL) that was requested by the FDA to address patch adhesion questions, information on the company’s manufacturing process with partner Corium Inc, and other analyses.
READ: Agile Therapeutics to resubmit Twirla contraceptive patch new drug application in second quarter
“We have resubmitted our NDA for Twirla as planned and look forward to working with the FDA during the review process,” said CEO Al Altomari. “Our achievement of this milestone reflects our commitment to broadening the available contraceptive treatment options for today’s women by offering an option to women seeking methods best suited to their needs and lifestyle.”
Altomari said Agile expects the FDA to acknowledge “our submission as a complete response” in about 30 days.
Twirla, also known as AG200-15, is designed to be applied once weekly for three weeks, followed by a week without a patch. The company has eight patents covering Twirla. It’s active ingredients are ethinyl estradiol, a type of synthetic estrogen, and levonorgestrel, a type of progestin.
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