�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 patch, which the company refers to by its internal product code AG-200-15. The Phase 2b safety and efficacy report successfully met its primary endpoint of ovulation suppression, cycle control and safety. The pharmacokinetic (PK) study demonstrated estrogen levels like with the well-established, low-dose oral preventative, LEVLEN�. There were no serious contrary events in either study. With the successful pharmacokinetic and Phase 2b safety and efficaciousness 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 mop up of the Phase 2b safety and efficacy sketch is an important pace forward in proving the safety and efficacy of Agile's important, new low-dose contraceptive patch. For eld, 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 birth control device 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 present that our product delivers an allow, low dose of estrogen, and an effective dosage 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 reliable adhesion and is well tolerated when worn for 7 days. Based upon these results, we have been able to blue-ribbon AG-200-15 as our campaigner for Phase 3 development. We are looking fore to discussing our results with the FDA and solidifying our Phase 3 plan."
Pharmacokinetic Study
The pharmacokinetic study was an open-label, randomized, relative, single-center, two-period cross-over study with 39 patients that evaluated deuce contraceptive patches to date if the systemic photo of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral preventative, LEVLEN�. As intended, both the EE and LNG exposure over time of both patches were less than LEVLEN� and ordered with the levels targeted by the company.
Phase 2b Study
In this multi-centered, multi-cycle Phase 2b condom and efficacy study of 123 women, the Company studied patches with different estrogen and progestin doses for trey cycles to identify the regimen providing the best efficacy (as demonstrated by ovulation inhibition), 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 superlative ovulation suppression with the best cycle per second control of the troika 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 day-by-day. The Company's low-dose, patented, round, soft, and flexible patch delivers 60 percentage less oestrogen than the only marketed patch available today, Ortho EVRA�. New market research conducted by Agile in 2008 with approximately 1,000 women of procreative age high spot that more than 30 percent of women are not slaked with their current preventive methods. In addition, the vast legal age of these women establish Agile's low-dose contraceptive temporary hookup appealing and over 50 percent would talk with their doctors about exploitation it. Agile's low-dose preventive patch is expected to fill a sizeable demand in the $6 trillion global ($2.5 1000000000 U.S.) hormonal contraceptive market.
About Estrogen
Estrogen is associated with certain common side effects, such as breast tenderness, bloating/weight advance and nausea. These side effects are believed to be related to the level of hormones delivered into the blood current, particularly with higher levels of estrogen. In some rare cases, high estrogen levels are thought to be linked with good, cardiovascular side effects in some women. Therefore, low doses of estrogen in hormonal contraception are coveted.
According to FDA labeling, women victimisation Ortho EVRA� are exposed to about 60 percent more estrogen than if they were using distinctive birth control pills. Increased levels of estrogen english hawthorn increase the risk of blood clots, which lead the FDA to add together precautions to Ortho EVRA's label.
About Agile Therapeutics, Inc.
Agile Therapeutics is a in private held, specialty pharmaceutical fellowship focused on the development of innovative women's health care products. Historically, the women's healthcare market place offers unique opportunities to a company with proven expertise in clinical maturation, regulatory personal matters, transdermal do drugs delivery and commercialization see.
Agile's electric current venture investors include TL Ventures, Novitas Capital (erstwhile PA Early Stage Partners), ProQuest Investments, and The Hillman Company. The Company has brocaded a total of $35 million in venture backing to date.
Agile Therapeutics, Inc.
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