Phase III Data Show Agile Therapeutics' Contraceptive Patch had Greater Compliance than an Oral Contraceptive
– Study Participants Had Fewer Missed Days of Contraception with Once-Weekly Patch than with Oral Contraceptive –
PRINCETON, N.J. – September 24, 2012 – Agile Therapeutics today announced findings from a phase III pivotal trial of AG200-15, Agile's investigational once-weekly combination contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG). In this comparative study, it was found that AG200-15 had significantly greater compliance (defined as no missed days of contraception in the cycle) than an oral contraceptive. The data were presented at Reproductive Health 2012, the Association of Reproductive Health Professionals Annual Meeting, taking place in New Orleans from September 20-22, 2012.
Data were presented from 1328 women, of whom 998 received the patch and 330 received an oral contraceptive. Over the first six cycles of the study, the percentage of cycles with perfect compliance was significantly higher in the patch group than in the Pill group (90.5% vs. 78.8%, p<0.001). Additionally, compliance with the patch improved over the six cycles, while compliance with the pill worsened.
The findings, prepared by researchers Drs. Andrew M. Kaunitz, David F. Archer, and Marie Foegh, were presented in a poster presentation at the meeting.
Andrew Kaunitz, MD, Associate Chair and Professor of the Department of Obstetrics and Gynecology at the University of Florida, and the Principal Investigator for the AG200-15 phase III trial, commented, "Noncompliance among contraceptive users is an ongoing challenge, as the effectiveness of a contraceptive can decrease if it is not used correctly. The once-weekly regimen of AG200-15 is intended to be simple to use correctly and we are encouraged to see that compliance was better with AG200-15 than with an oral contraceptive."
Agile recently filed the NDA for AG200-15 with the Food and Drug Administration and anticipates a response in the first quarter of 2013.
About AG200-15
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.