Agile Therapeutics announced that it has resubmitted the New Drug Application (NDA) for Twirla, an investigational, low-dose combined hormonal contraceptive patch.
The Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Agile in February 2013 requesting additional data on the product’s safety and efficacy as well as the manufacturing process. In the NDA resubmission, the Company included safety and efficacy data from the Phase 3 trial SECURE, the manufacturing information, and a summary response to the CRL.
Twirla, also known as AG200-15, is intended to be a once-weekly prescription contraceptive patch. It combines ethinyl estradiol, a synthetic estrogen, and levonorgestrel, a progestin. Twirla utilizes the proprietary Skinfusion technology that provides both hormones over 1 week at levels similar to currently available low-dose oral contraceptives. The patch is to be applied once a week for 3 weeks, then removed for 1 week.
Agile is anticipating a Prescription Drug User Free Act (PDUFA) date based on a 6-month review after the FDA acknowledges receipt of the NDA submission.
For more information visit AgileTherapeutics.com.