�Agile Therapeutics, Inc.,
proclaimed that it successfully accomplished two cay clinical trials in
the development of the company's new, innovational low-dose, once-weekly,
contraceptive patch, which the company refers to by its national product
computer code AG-200-15. The Phase 2b safety and efficacy study successfully met its
basal endpoint of ovulation curtailment, cycle control and safety. The
pharmacokinetic (PK) study demonstrated estrogen levels comparable with the
well-established, low-dose oral contraceptive device, 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 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 penis of
Agile's Scientific Advisory Board, commented, "Successful culmination 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 old age, 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 prophylactic 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 march that our product delivers an set aside, low loony toons of
oestrogen, 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 venus's curse for our Phase 3 program, as well demonstrate that our
plot of ground 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
prospect for Phase 3 growth. We are looking frontwards 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
deuce contraceptive patches to ascertain if the systemic exposure of ethinyl
estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose
oral birth control device, LEVLEN(R). As intended, both the EE and LNG exposure
over time of both patches were less than LEVLEN(R) 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 trey cycles to identify the regimen providing the topper
efficacy (as demonstrated by ovulation suppression), cycle control and
tolerability at the lowest hormonal dose. Top-line results from the trial
showed at that place was a clear dose-response to ovulation suppression and cycle
control. AG-200-15 provided the superlative ovulation curtailment with the
best oscillation control of the iII regimens studied.
About Agile's Product
Agile's low-dose contraceptive patch offers women a commodious, once-
weekly form of birth control condition. Many women prefer a weekly patch over having
to commemorate to pack the tab daily. The Company's low-dose, patented,
rhythm, soft, and flexible patch delivers 60 percent less estrogen than the
only marketed patch available today, Ortho EVRA(R). New market place research
conducted by Agile in 2008 with more or less 1,000 women of reproductive
age highlight that more than 30 percent of women are not satisfied with
their current contraceptive methods. In add-on, the immense majority of
these women found Agile's low-dose preventative patch appealing and over
50 percentage would talk with their doctors about using it. Agile's low-dose
contraceptive fleck is expected to make full a goodish need in the $6 billion
spherical ($2.5 billion U.S.) hormonal preventative market.
About Estrogen
Estrogen is associated with certain common side personal effects, such as breast
softheartedness, bloating/weight acquire and nausea. These side effects ar
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 oestrogen levels ar thought to be joined with severe, cardiovascular
side effects in some women. Therefore, abject doses of estrogen in hormonal
contraceptive method are desired.
According to FDA labeling, women using Ortho EVRA(R) are open to
or so 60 percentage more oestrogen than if they were using typical birth
control pills. Increased levels of estrogen may increase the risk of blood
clots, which lead story the FDA to add precautions to Ortho EVRA's label.
About Agile Therapeutics, Inc.
Agile Therapeutics is a privately held, specialty pharmaceutic
company focussed on the development of innovative women's healthcare
products. Historically, the women's healthcare market offers unique
opportunities to a company with proven expertness in clinical development,
regulative affairs, transcutaneous 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 billion in venture funding
to date. For more entropy, 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)
Agile Therapeutics, Inc.
http://www.agiletherapeutics.com
View drug data on Estradiol.
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