Agile Therapeutics, Inc., a renowned New Jersey based women’s healthcare and pharmaceutical company, has reportedly announced the positive outcome of a recent U.S. FDA Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) meeting held to discuss Agile’s New Drug Application (NDA) for Twirla® (AG200-15), the company’s lead candidate.

Twirla is the company’s investigational combined-hormonal contraceptive (CHC) patch, which is made up of levonorgestrel (LNG), a progestin, and ethinyl estradiol (EE), an estrogen. The BRUDAC meeting saw Twirla receive a majority vote; 14 to one, with one abstention, over the assessment that the benefits of the candidate in prevention of pregnancy far outweigh the overall risk.

The Chief Executive Officer and Chairman of Agile Therapeutics, Al Altomari stated that the company is pleased that the FDA committee voted in favor of the company’s investigational product candidate. The favorable vote represents an integral milestone towards the company’s journey of delivering a novel, innovative contraceptive for women.

Altomari further added that the company now looks forward to continuing its dialogue with the Food and Drug Administration regarding the crucial data presented at the meeting and working for the potential FDA approval of the product.

According to reports, the Twirla contraceptive patch is based upon the company’s proprietary transdermal patch technology, named Skinfusion®. The Skinfusion technology has been specifically designed to facilitate drug delivery through the patient’s skin.

The contraceptive patch is designed to be applied to the skin once a week for a period of three weeks, which would be followed by a week-long period without the patch. Agile has completed the product’s Phase 3 clinical trial and is currently seeking to obtain a regulatory approval in the United States after the New Drug Application resubmission.

Agile Therapeutics resubmitted the NDA for the CHC patch back on 16^th May 2019. The FDA takes the BRUDAC’s non-binding vote into consideration as a part of the NDA evaluation.

The FDA has now assigned November 16, 2019 as the Prescription Drug User Fee Act (PDUFA) goal date for completion of the Twirla NDA review.
 

Source credit: https://ir.agiletherapeutics.com/news-releases/news-release-details/agile-therapeutics-announces-favorable-outcome-fda-advisory