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Agile Therapeutics Achieves Phase 2 Study Endpoints in Key Clinical Trials with New, Innovative Low-Dose Contraceptive Patch
Date:9/3/2008

of the progestin, levonorgestrel. We are very pleased with the clinical outcomes, which, in addition to helping us select the optimal dose for our Phase 3 program, also demonstrate that our patch gives reliable adhesion and is well tolerated when worn for 7 days. Based upon these results, we have been able to select AG-200-15 as our candidate for Phase 3 development. We are looking forward to discussing our results with the FDA and solidifying our Phase 3 plan."

Pharmacokinetic Study

The pharmacokinetic study was an open-label, randomized, comparative, single-center, two-period cross-over study with 39 patients that evaluated two contraceptive patches to see if the systemic exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral contraceptive, LEVLEN(R). As intended, both the EE and LNG exposure over time of both patches were less than LEVLEN(R) and consistent with the levels targeted by the company.

Phase 2b Study

In this multi-centered, multi-cycle Phase 2b safety and efficacy study of 123 women, the Company studied patches with different estrogen and progestin doses for three cycles to identify the regimen providing the best efficacy (as demonstrated by ovulation suppression), cycle control and tolerability at the lowest hormonal dose. Top-line results from the trial showed there was a clear dose-response to ovulation suppression and cycle control. AG-200-15 provided the greatest ovulation suppression with the best cycle control of the three regimens studied.

About Agile's Product

Agile's low-dose contraceptive patch offers women a convenient, once- weekly form of birth control. Many women prefer a weekly patch over having to remember to take the pill daily. The Company's low-dose, patented, round, soft, and flexible patch delivers 60 percent less estrogen than the only marketed patch available today, Ortho EVRA(R). New market research conducted by Agile in 2008 with approximately
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SOURCE Agile Therapeutics, Inc.
Copyright©2008 PR Newswire.
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