Company to Discuss Phase 3 Plans with FDA
PRINCETON, N.J., Sept. 3 /PRNewswire/ -- Agile Therapeutics, Inc., announced today that it successfully completed two key clinical trials in the development of the company's new, innovative low-dose, once-weekly, contraceptive patch, which the company refers to by its internal product code AG-200-15. The Phase 2b safety and efficacy study successfully met its primary endpoint of ovulation suppression, cycle control and safety. The pharmacokinetic (PK) study demonstrated estrogen levels comparable with the well-established, low-dose oral contraceptive, LEVLEN(R). There were no serious adverse events in either study. With the successful pharmacokinetic and Phase 2b safety and efficacy study results, the Company will discuss its Phase 3 plans for AG-200-15 with the Food and Drug Administration (FDA).
Daniel R. Mishell, M.D., Professor in the Department of Obstetrics and Gynecology at the University of Southern California, and a member of Agile's Scientific Advisory Board, commented, "Successful completion of the Phase 2b safety and efficacy study is an important step forward in proving the safety and efficacy of Agile's important, new low-dose contraceptive patch. For years, OB/GYN's have been recommending low-dose oral contraceptives to their patients considering hormone-based contraceptives. If shown to be safe and effective, a low-dose, once-weekly contraceptive patch would be a natural and needed addition to the hormonal-based contraceptives and an alternative to once-daily oral contraceptives."
Thomas Rossi, Ph.D., Agile's President and Chief Executive Officer, commented on the top-line data, "The purpose of conducting these studies was to demonstrate that our product delivers an appropriate, low dose of estrogen, and an effective dose 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."
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 1,000 women of reproductive age highlight that more than 30 percent of women are not satisfied with their current contraceptive methods. In addition, the vast majority of these women found Agile's low-dose contraceptive patch appealing and over 50 percent would talk with their doctors about using it. Agile's low-dose contraceptive patch is expected to fill a sizeable need in the $6 billion global ($2.5 billion U.S.) hormonal contraceptive market.
Estrogen is associated with certain common side effects, such as breast tenderness, bloating/weight gain and nausea. These side effects are believed to be related to the level of hormones delivered into the blood stream, particularly with higher levels of estrogen. In some rare cases, high estrogen levels are thought to be linked with serious, cardiovascular side effects in some women. Therefore, low doses of estrogen in hormonal contraception are desired.
According to FDA labeling, women using Ortho EVRA(R) are exposed to about 60 percent more estrogen than if they were using typical birth control pills. Increased levels of estrogen may increase the risk of blood clots, which lead the FDA to add precautions to Ortho EVRA's label.
About Agile Therapeutics, Inc.
Agile Therapeutics is a privately held, specialty pharmaceutical company focused on the development of innovative women's healthcare products. Historically, the women's healthcare market offers unique opportunities to a company with proven expertise in clinical development, regulatory affairs, transdermal drug delivery and commercialization experience.
Agile's current venture investors include TL Ventures, Novitas Capital (formerly PA Early Stage Partners), ProQuest Investments, and The Hillman Company. The Company has raised a total of $35 million in venture funding to date. For more information, please visit http://www.agiletherapeutics.com.
LEVLEN(R) is a registered trademark of Berlex Laboratories
Ortho EVRA(R) is a registered trademark of OrthoMcNeil(TM)
|SOURCE Agile Therapeutics, Inc.|
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