Sklya: The newest IUD, released in January 2013. See their press release below:
WAYNE, N.J., Jan. 9, 2013
/PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced
that the U.S. Food and Drug Administration (FDA) approved Skyla™
(levonorgestrel-releasing intrauterine system) 13.5 mg, a new
hormone-releasing system that is placed in the uterus for the prevention
of pregnancy for up to three years.[1]
"Research shows that nearly 50 percent of pregnancies in the U.S. are unintended,2 which emphasizes the need for increased education and access to effective birth control options," said Anita L. Nelson , M.D., Professor of Obstetrics and Gynecology at Harbor-UCLA Medical Center, Torrance, CA. "Skyla is more than 99 percent effective at preventing pregnancy and
may be appropriate for women who want a birth control method that they
do not have to take daily. Further, Skyla may be used by women whether
or not they have ever had a child, representing an important new choice
for women who don't want to become pregnant for up to three years."
Skyla is a small, flexible plastic T-shaped device containing 13.5 mg of a progestin hormone called levonorgestrel. The
size of the Skyla T-body is 28mm x 30mm and the outer diameter of the
placement tube is 3.8mm. Because Skyla slowly releases levonorgestrel
into the uterus, only small amounts of the hormone enter the blood.
During the first three to six months of using Skyla, women may
experience irregular periods and an increase in the number of bleeding
days. Women may also have frequent spotting or light bleeding. Some
women may have heavy bleeding during this time. After using Skyla for a
while, the number of bleeding and spotting days is likely to lessen, and
there is a small chance that periods may stop altogether.1,3
Women
can have Skyla placed by a healthcare provider during an in-office
visit. Skyla is intended for long-term use for up to three years but may
be removed by a healthcare provider at any time. Women could become
pregnant as soon as Skyla is removed, so they should use another method
of birth control if they do not want to become pregnant. About 77% of
women who want to become pregnant will become pregnant sometime in the
first year after Skyla is removed.3
"The
approval of Skyla expands Bayer's IUD portfolio and highlights our
continued commitment to empower women with a variety of birth control
options at different reproductive stages of their lives," said Pamela A. Cyrus ,
M.D., Vice President and Head of U.S. Medical Affairs, Bayer HealthCare
Pharmaceuticals. "We are pleased to bring the first new IUD to market
in the U.S. in 12 years, and to provide women who are seeking
contraception with an important new and effective option to consider
with their healthcare providers."
Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg will be available by prescription the week of February 11.
About the Clinical Trial for Skyla1
The approval of Skyla is supported by data from a Phase 3
trial that included 1,432 women aged 18-35 who received Skyla, of which
38.8% (556) had not yet had a child. The trial was a multicenter,
multinational, randomized open-label study conducted in 11 countries in Europe, Latin America, the U.S. and Canada.
Women less than six weeks postpartum, with a history of ectopic
pregnancy, with clinically significant ovarian cysts or with HIV or
otherwise at high risk for sexually transmitted infections were excluded
from the trial.
The
pregnancy rate calculated as the Pearl Index (PI) in women aged 18-35
years was the primary efficacy endpoint used to assess contraceptive
reliability. The PI was calculated based on 28-day equivalent exposure
cycles; evaluable cycles excluded those in which back-up contraception
was used unless a pregnancy occurred in that cycle. Skyla-treated women
provided 15,763 evaluable 28-day cycle equivalents in the first year and
39,368 evaluable cycles over the three-year treatment period. The PI
estimate for the first year of use based on the five pregnancies that
occurred after the onset of treatment and within seven days after Skyla
removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96.
The cumulative three-year pregnancy rate, based on 10 pregnancies,
estimated by the Kaplan-Meier method was 0.9 per 100 women or 0.9%, with
a 95% upper confidence limit of 1.7%.
Of
Skyla-treated women, 21.9% discontinued the study treatment due to an
adverse event. Most common adverse reactions (occurring in greater than
or equal to 5% users) were, vulvovaginitis (20.2%), abdominal/pelvic
pain (18.9%), acne/seborrhea (15.0%), ovarian cyst (13.2%), headache
(12.4%), dysmenorrhea (8.6%), breast pain/discomfort (8.6%), increased
bleeding (7.8%) and nausea (5.5%).
Other
serious adverse reactions were also observed, including
ectopic/intrauterine pregnancy, life-threatening infections, pelvic
inflammatory disease (PID), perforation and expulsion.
Important Safety Information for Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg
If
you have a pelvic infection, get infections easily, or have certain
cancers, don't use Skyla. Less than 1% of users get a serious infection
called pelvic inflammatory disease.
If
you have persistent pelvic or stomach pain or if Skyla comes out, tell
your doctor. If Skyla comes out, use back-up birth control. Skyla may
attach to or go through the uterus and cause other problems.
Pregnancy
while using Skyla is uncommon but can be life threatening and may
result in loss of pregnancy or fertility. Ovarian cysts may occur but
usually disappear.
Bleeding
and spotting may increase in the first few months, and remain
irregular. Over time, periods are likely to become shorter and lighter,
or may stop.
Skyla does not protect against HIV or STDs.
Only you and your healthcare provider can decide if Skyla is right for you. Skyla is available by prescription only.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
For additional information about Skyla, please see full prescribing information at
www.skyla-us.com.
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based
pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer
AG. Bayer HealthCare is one of the world's leading, innovative companies
in the healthcare and medical products industry, and combines the
activities of the Animal Health, Consumer Care, Diabetes Care, and
Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer
HealthCare Pharmaceuticals provides products for Diagnostic Imaging,
General Medicine, Hematology, Neurology, Oncology and Women's
Healthcare. The company's aim is to discover and manufacture products
that will improve human health worldwide by diagnosing, preventing and
treating diseases.
BAYER® and the Bayer Cross® are registered trademarks of Bayer. Skyla is a trademark of Bayer.