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Agile Therapeutics Announces Presentation of SECURE Phase 3 Data at the 2017 Congress on Women's Health
PRINCETON, N.J., April 27, 2017 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (NASDAQ:AGRX), a women's healthcare company announced today that a presentation entitled "An Update on Hormonal Contraception and The Changing U.S. Population" will be presented by Co-Principal Investigator of the SECURE clinical trial, Anita Nelson, MD, Professor and Chair, Obstetrics and Gynecology, College of Osteopathic Medicine of the Pacific at the 25th Anniversary Congress on Women's Health, jointly sponsored by the Academy of Women's Health and Journal of Women's Health, on April 29, 2017 at 7:00am ET at the Crystal Gateway Marriott in Arlington, VA. The presentation will focus on real-world contraceptive study design and outcomes.
The presentation will include data from the Phase 3 clinical trial evaluating Twirla®, also known as the SECURE clinical trial. SECURE was a one-year, multicenter, single-arm, open-label trial that evaluated the safety, efficacy and tolerability of Twirla in 2032 healthy women, aged 18 and over, at 102 experienced investigative sites across the United States. Agile announced top-line results of the SECURE clinical trial in January 2017.
The Company plans to resubmit its new drug application for Twirla to the U.S. Food and Drug Administration by the end of the second quarter of 2017.
About Agile Therapeutics, Inc.
Agile Therapeutics is a forward-thinking women's healthcare company dedicated to fulfilling the unmet health needs of today's women. Our product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method. Our lead product candidate, Twirla®, (ethinyl estradiol and levonorgestrel transdermal system), also known as AG200-15, is a once-weekly prescription contraceptive patch that recently completed Phase 3 trials. Twirla is based on our proprietary transdermal patch technology, called Skinfusion®, which is designed to provide advantages over currently available patches and is intended to optimize patch adhesion and patient wearability. For more information, please visit the company website at www.agiletherapeutics.com. The company may occasionally disseminate material, nonpublic information on the company website.
Certain information contained in this press release includes "forward-looking statements" related to the Company's regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates", "estimates," "expects," "plans," "intends," "may," "could," 'might," "will," "should" or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions and uncertainties. Any or all of the forward-looking statements may turn out to be wrong, or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. Our statements about the planned resubmission of our NDA for Twirla could be affected by the potential that additional analyses of issues identified in our complete response letter from the FDA are required to be completed that were not previously anticipated, that our ongoing tests to support our resubmission are not completed on time, that the third parties we rely on to perform services in support of our NDA resubmission do not complete their work in a timely fashion and that other issues will arise that will delay resubmission of our NDA or negatively impact acceptance, review and approval of Twirla by the FDA. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. All forward looking statements are subject to risks detailed in our filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.
Contact: Mary Coleman -- 609-356-1921