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
(firmenpresse) - PRINCETON, NJ -- (Marketwire) -- 09/24/12 -- 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.
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.
Agile Therapeutics is a pharmaceutical development company specializing in Women's Healthcare, with an initial focus on providing women with more options for convenient methods of hormonal contraception. The company's lead investigational product, AG200-15, is a once-weekly contraceptive patch that has been submitted to the FDA for approval. In addition, Agile is also developing a 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 designed for dependable adhesion over seven days. For more information, please visit .
Reproductive Health is the premier conference in reproductive and sexual health sponsored annually by ARHP. This clinical conference combines the latest research science with interactive, hands-on training and offers take home points for immediate practice improvement.
The Association of Reproductive Health Professionals (ARHP) is the leading source for trusted medical education and information on reproductive and sexual health. ARHP educates health care providers, informs consumers, and helps shape public policy. ARHP is a non-profit membership association composed of highly qualified and committed experts in reproductive health. ARHP members are health professionals in clinical practice, education, research, and advocacy and they include physicians, nurse practitioners, physician assistants, nurse midwives, researchers, educators, pharmacists, and other professionals in reproductive health. To learn more, visit: .
Chantal Beaudry/Karen Famighetti for Agile Therapeutics
212-867-1762
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Datum: 24.09.2012 - 14:45 Uhr
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