Agile Therapeutics Announces Completion of Patient Recruitment in Twirla(R) Phase 3 SECURE Clinical Trial
"We have completed active recruitment of patients into our Phase 3 SECURE clinical trial, which is a crucial milestone in the trial and for Agile," said
Twirla is the Company's lead product candidate and is a combined hormonal contraceptive patch that contains the active ingredients ethinyl estradiol and levonorgestrel, both of which have an established history of efficacy and safety in currently marketed combination low-dose oral contraceptives. Twirla was developed using Agile's proprietary Skinfusion® technology to deliver both hormones over a seven-day period at levels comparable to currently marketed low-dose oral contraceptives. Twirla is applied once weekly for three weeks followed by a patch-free week, and is designed to promote patient compliance.
"The Phase 3 SECURE clinical trial is progressing with continued focus on excellent study conduct," stated
The SECURE study is a multicenter Phase 3 clinical trial of Twirla which will enroll approximately 2,100 female subjects who will receive treatment for up to one year. The study will assess the effectiveness of the patch in preventing pregnancy using the Pearl Index as the primary contraceptive efficacy measure. Safety and tolerability will also be evaluated.
About
Forward-Looking Statement
Certain information contained in this press release includes "forward-looking statements" related to the Company's, projected timeline for clinical trials and potential market opportunity for its product candidates. 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 about the timing and
conduct of our clinical trial could be affected by the potential that we experience difficulty in 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; our statements about the potential commercial opportunity could be affected by the potential that our product does not receive regulatory approval, does not receive reimbursement by third party payors, or a commercial market for the product does not develop because of any of the risks inherent in the commercialization of contraceptive products. 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
CONTACT:Source:Mary Coleman -- 609-356-1921
News Provided by Acquire Media