PRINCETON, NJ--(Marketwired - May 06, 2013) -
Agile Therapeutics today announced positive results from two Phase 3 clinical studies of AG200-15, the company's investigational, once-weekly low-dose combination contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG). The results were presented at the American College of Obstetricians and Gynecologists' (ACOG) 61st Annual Clinical Meeting, taking place in New Orleans, Louisiana, from May 4 to 8, 2013.
The data analysis, Efficacy and Safety of Twirla™, A Novel Contraceptive Patch, in Two Comparative Phase 3 Studies, examined the efficacy and tolerability of AG200-15 in healthy women compared to low-dose combination oral contraceptives (COCs). The pregnancy rate was comparable for AG200-15 and COCs for all subjects. Andrew Kaunitz, M.D., Associate Chair and Professor of the Department of Obstetrics and Gynecology at the University of Florida, presented the analysis in a poster session on May 6.
A second poster presentation, Adhesion of Twirla™, A New Low-Dose Contraceptive Patch, In a Phase 3 Study, reported that AG200-15 had a low incidence of patch fall-off, skin irritation, and itching in a clinical trial conducted in a highly diverse population of over 1,200 women. The data was presented by David F. Archer, M.D., Director of the Clinical Research Center at the Jones Institute for Reproductive Medicine at Eastern Virginia Medical School.
AG200-15 is an investigational combination hormonal contraceptive patch, designed to deliver a low dose of ethinyl estradiol comparable to low-dose combination oral contraceptives. The phase III trials for AG200-15 enrolled nearly 2,000 women and formed the basis for the Company's application to the US Food and Drug Administration in 2012. The AG200-15 patch is intended to be applied once weekly for three weeks, followed by a fourth, patch-free week. The patch is designed using a soft, flexible cloth, with a silky feel, and is intended to provide excellent adhesion, comfort, and appearance.
About Agile Therapeutics
Agile Therapeutics is a pharmaceutical development company specializing in Women's Healthcare products, with an initial focus on providing women with more options and potentially more convenient methods of hormonal contraception. The Company's lead investigational product, AG200-15, is designed to be a once-weekly contraceptive patch that has recently been submitted to the FDA as a New Drug Application (NDA) for review. In addition, Agile is also developing a low dose, progestin-only contraceptive patch, AG890 (formerly AG900). Both AG200-15 and AG890 incorporate proprietary transdermal delivery technology, Skinfusion®, developed by Agile, consisting of an active and peripheral adhesive system that has been designed to allow stable drug delivery and dependable adhesion over seven days. For more information, please visit http://www.agiletherapeutics.com.