PRINCETON, N.J., Dec. 1, 2014 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (Nasdaq:AGRX) today announced the publication of two manuscripts containing data from a Phase 3 clinical trial of Twirla® (AG200-15), an investigational, once-weekly contraceptive patch.
Kaunitz A, Portman D, Westhoff C, Mishell D, Archer D, Foegh M. New Contraceptive Patch Wearability Assessed by Investigators and Participants in a Randomized, Phase 3 Study. Contraception 2014 DOI: http://dx.doi.org/10.1016/j.contraception.2014.11.013
Kaunitz A, Portman D, Westhoff C, Archer D, Mishell, D, Foegh M. Self-Reported and Verified Compliance in a Phase 3 Clinical Trial of a Novel Low-Dose Contraceptive Patch and Pill. Contraception 2014 DOI: http://dx.doi.org/10.1016/j.contraception.2014.11.011
Agile recently initiated an additional Phase 3 trial with Twirla, the SECURE study, which will provide further data on the safety, tolerability, and effectiveness of this low-dose contraceptive patch.
Agile Therapeutics is a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products. Our product candidates are designed to provide women with contraceptive options that offer greater convenience and facilitate compliance. Our lead product candidate, Twirla®, (ethinyl estradiol and levonorgestrel transdermal system), also known as AG200-15, is a once-weekly prescription contraceptive patch currently in Phase 3 clinical development. 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 adherence and patient acceptability. For more information, please visit the company website at www. agiletherapeutics.com.
Forward Looking Statement
Certain information contained in this press release includes "forward-looking statements" related to the Company's clinical trials. 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 expectations 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. For example, our statements regarding our statements about the timing and conduct of our clinical trial could be affected by the potential that we experience difficulty in identifying and initiating sites and enrolling subjects, we identify serious side effects or other safety issues, we do not have clinical supply of our product candidate that is adequate in amount and quality and supplied in a timely fashion, and the inherent risks of clinical development. 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 Registration Statement on Form S-1, and the prospectus filed in connection therewith and our 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 609-683-1880Source:Agile Therapeutics