�Agile Therapeutics, Inc., proclaimed that it successfully completed two key clinical trials in the development of the company's new, innovative low-dose, once-weekly, contraceptive maculation, which the company refers to by its interior product code AG-200-15. The Phase 2b safety and efficacy study successfully met its primary endpoint of ovulation inhibition, cycle control and safety. The pharmacokinetic (PK) study demonstrated oestrogen levels comparable with the well-established, low-dose oral preventive, LEVLEN�. There were no serious inauspicious events in either sketch. With the successful pharmacokinetic and Phase 2b condom and efficacy study results, the Company will hash out 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 windup 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 long time, OB/GYN's take in been recommending low-dose oral contraceptives to their patients considering hormone-based contraceptives. If shown to be safe and efficacious, a low-dose, once-weekly preventive patch would be a natural and needed gain 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 certify that our product delivers an capture, low acid of oestrogen, and an effective dose of the progestin, levonorgestrel. We ar very proud of with the clinical outcomes, which, in addition to helping us select the optimal dose for our Phase 3 program, too demonstrate that our patch gives dependable adhesion and is well tolerated when worn for 7 days. Based upon these results, we sustain been able to prime AG-200-15 as our campaigner for Phase 3 developing. We are looking ahead 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 report with 39 patients that evaluated iI contraceptive patches to see if the systemic exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral preventive, LEVLEN�. As intended, both the EE and LNG exposure over time of both patches were less than LEVLEN� and uniform with the levels targeted by the company.
Phase 2b Study
In this multi-centered, multi-cycle Phase 2b safety and efficaciousness study of 123 women, the Company studied patches with different estrogen and progestin doses for tercet 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 inhibition with the best cycle control of the deuce-ace regimens studied.
About Agile's Product
Agile's low-dose contraceptive mend offers women a commodious, once-weekly manikin of birth control. Many women favor a weekly patch over having to remember to take the pill daily. The Company's low-dose, patented, round, cushy, and flexible patch delivers 60 pct less estrogen than the only marketed patch available today, Ortho EVRA�. New market inquiry conducted by Agile in 2008 with approximately 1,000 women of procreative age highlighting that more than 30 percent of women ar not satisfied with their current contraceptive methods. In addition, the vast majority of these women establish Agile's low-dose contraceptive bandage appealing and over 50 percent would talk with their doctors about victimisation it. Agile's low-dose contraceptive patch is expected to fill a sizeable want in the $6 billion global ($2.5 zillion U.S.) hormonal contraceptive market.
About Estrogen
Estrogen is associated with certain usual side effects, such as breast tenderness, bloating/weight put on and nausea. These incline effects are believed to be related to to the level of hormones delivered into the blood flow, particularly with higher levels of oestrogen. In some rare cases, high oestrogen levels are thought to be linked with grave, cardiovascular side effects in some women. Therefore, low-pitched doses of estrogen in hormonal contraception are sought after.
According to FDA labeling, women using Ortho EVRA� are uncovered to around 60 percent more estrogen than if they were using typical birth controller pills. Increased levels of estrogen crataegus oxycantha 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, distinctiveness pharmaceutical company focused on the development of forward-looking women's health care products. Historically, the women's healthcare grocery offers unique opportunities to a company with proven expertise in clinical development, regulatory affairs, transdermal drug delivery and commercialization see.
Agile's flow venture investors include TL Ventures, Novitas Capital (once PA Early Stage Partners), ProQuest Investments, and The Hillman Company. The Company has elevated a total of $35 million in venture financing to date.
Agile Therapeutics, Inc.
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