PRINCETON, NJ--(Marketwire - September 20, 2012) -
Agile Therapeutics announced today that Dr. Marie Foegh, Chief Medical Officer and Vice President of Clinical Research and Development, will be presenting at CBI's Forum on Phase II-III Clinical Study Optimization. The event takes place September 20-21, 2012 in Chicago.
Dr. Foegh's presentation will focus on the recent decline in compliance in clinical trials. It will examine recent patterns of clinical trial enrollment in the United States, the importance of enrolling minorities in clinical trials, predictors of noncompliance, and possible solutions to the problem of noncompliance. Dr. Foegh will also discuss her experience leading the Phase III trials for Agile's investigational once weekly contraceptive patch, AG200-15, which is designed to deliver a low daily estrogen dose.
Agile recently filed the NDA for AG200-15 and anticipates a response in the first quarter of 2013.
"I am looking forward to sharing our experience with compliance in the Phase III trials of AG200-15 at CBI's forum," said Dr. Foegh. "Our recent studies have allowed us to gain valuable insights into the issue of noncompliance in clinical studies and I am excited to discuss our experience and to share with conference attendees possible strategies to help address the problem."
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, 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 http://www.agiletherapeutics.com.
About CBI's Forum on Phase II-III Clinical Study Optimization
CBI's Forum on Phase II-III Clinical Study Optimization, taking place September 20-21, 2012 in Chicago, provides insight into the latest challenges and solutions of executing successful, efficient and cost-effective Phase II and III studies. The conference will cover topics including current landscape and drivers shaping Phase I-II research, budget tracking measures for continuous monitoring of trial costs, best practices and strategies for global Phase I-II studies, industry approaches for navigating clinical outsourcing and site selection, cutting-edge enrollment techniques to improve patient recruitment and retention, and the latest insights on risk-based approaches to clinical monitoring in Phase I-II studies. For more information please visit http://www.cbinet.com/conference/pc12024.
CBI, an Advanstar company, is the leading provider of market-driven, unbiased conferences for the pharmaceutical, biotechnology, medical device and healthcare industries. CBI offers specialized information presented in interactive formats by thought leaders and regulators.
Delegates, speakers and sponsors leverage CBI to exchange timely information on the products, processes and technology driving innovation in industry. Founded in 1995, CBI continues its tradition of creating conferences covering the latest investment opportunities, business strategies, domestic and international regulatory issues and technologies. CBI events also provide extensive opportunities for networking and discussion with senior policy and decision makers. For more information please visit www.cbinet.com.