Agile Therapeutics has resubmitted to the Food and Drug Administration (FDA) the New Drug Application (NDA) for its product, Twirla, an investigational low-dose combined hormonal contraceptive patch (AG200-15).
Based on the results from a comparative wear study, the resubmitted NDA will address the FDA’s questions on in vivo adhesion, additional information on the Company’s manufacturing process, and other analyses responding to the 2017 Complete Response Letter (CRL).
“We have resubmitted our NDA for Twirla as planned and look forward to working with the FDA during the review process […] We expect the FDA to acknowledge our submission as a complete response in approximately 30 days, and at the same time provide us with a Prescription Drug User Fee Act (PDUFA) date that we anticipate will be based on a 6-month review,” said Al Altomari, Chairman and Chief Executive Officer of Agile.
The Twirla contraceptive patch contains ethinyl estradiol, a synthetic estrogen, and levonorgestrel, a progestin. It utilizes a proprietary technology that delivers both hormones over 1 week at levels similar to currently available low-dose oral contraceptives. The patch is applied once a week for 3 weeks, followed by a patch-free week.
For more information visit AgileTherapeutics.com.