SAN FRANCISCO and DUBLIN, Sept. 7,
2016 /PRNewswire/ -- Medicines360, a nonprofit global
women's health pharmaceutical company, and Allergan, plc (NYSE:
AGN), a leading global pharmaceutical company, today announced the
publication of five-year levonorgestrel release rates for
LILETTA® (levonorgestrel-releasing intrauterine
system) 52 mg in the September 2016
issue of the medical journal Contraception.
"This study was conducted to understand the duration of action
for LILETTA," said lead author Mitchell
Creinin, MD, Professor and Director of Family Planning in
the Department of Obstetrics and Gynecology at the University of California, Davis.
The study evaluated the remaining hormone content in LILETTA
systems that had been removed from women at various time points
during the first five years of the ongoing seven-year ACCESS IUS
(A Comprehensive Contraceptive Efficacy
and Safety Study of an IUS) clinical trial, the
largest ever IUS clinical trial conducted in the US. The remaining
amount of levonorgestrel, the active hormone in LILETTA, was used
to calculate the hormone release rate over five years.
"The study's findings," according to Dr. Creinin, "show that the
amount of levonorgestrel remaining in the system and the amount
still being released each year support the continued evaluation of
LILETTA as a contraceptive for up to five years."
"In addition, the study results support our planned future FDA
submission for a five-year duration of use for LILETTA," said Dr.
Jessica Grossman, CEO of
Medicines360.
About LILETTA
LILETTA is a hormone-releasing system placed in a woman's uterus
to prevent pregnancy. It is greater than 99 percent effective for
up to three years. LILETTA has been approved by the FDA for
contraception in the U.S. for 3 years based on the initial results
of the ACCESS IUS trial and has been approved in several European
countries for contraception with additional indications for the
treatment of heavy menstrual bleeding. LILETTA is not permanent, it
is reversible; it can be removed at any time by a healthcare
provider, offering the flexibility of use for either long- or
short-term contraception.
Important Safety Information
(scroll to see additional Important Safety Information and
full Prescribing Information link)
Who is not appropriate for LILETTA
Use of LILETTA is contraindicated in women with: known or
suspected pregnancy and cannot be used for post-coital
contraception; congenital or acquired uterine anomaly, including
fibroids if they distort the uterine cavity; known or suspected
breast cancer or other progestin-sensitive cancer, now or in the
past; known or suspected uterine or cervical neoplasia; acute liver
disease or liver tumors; untreated acute cervicitis or vaginitis,
including lower genital tract infections (e.g., bacterial
vaginosis) until infection is controlled; postpartum endometritis
or infected abortion in the past 3 months; unexplained uterine
bleeding; current IUS; acute pelvic inflammatory disease (PID) or
history of PID (except with later intrauterine pregnancy);
conditions increasing susceptibility to pelvic infection; or
hypersensitivity to any component of LILETTA.
Clinical considerations for use and removal of
LILETTA
Use LILETTA with caution after careful assessment in patients
with coagulopathy or taking anticoagulants; migraine, focal
migraine with asymmetrical visual loss, or other symptoms
indicating transient cerebral ischemia; exceptionally severe
headache; marked increase of blood pressure; or severe arterial
disease such as stroke or myocardial infarction. Consider removing
the intrauterine system if these or the following arise during use:
uterine or cervical malignancy or jaundice. Because irregular
bleeding/spotting is common during the first months of LILETTA use,
exclude endometrial pathology (polyps or cancer) prior to the
insertion of LILETTA in women with persistent or uncharacteristic
bleeding. If the threads are not visible or are significantly
shortened, they may have broken or retracted into the cervical
canal or uterus. If LILETTA is displaced (e.g., expelled or
perforated the uterus), remove it.
Pregnancy related risks with LILETTA
If pregnancy should occur with LILETTA in place, remove the
intrauterine system because leaving it in place may increase the
risk of spontaneous abortion and preterm labor. Removal or
manipulation may result in pregnancy loss. Evaluate women for
ectopic pregnancy because the likelihood of a pregnancy being
ectopic is increased with LILETTA. Tell women about the signs of
ectopic pregnancy and associated risks, including loss of
fertility. Women with a history of ectopic pregnancy, tubal
surgery, or pelvic infection carry a higher risk of ectopic
pregnancy.
Educate her about PID
Insertion of LILETTA is contraindicated in the presence of known
or suspected PID or endometritis or a history of PID unless there
has been a subsequent intrauterine pregnancy. IUSs have been
associated with an increased risk of PID, most likely due to
organisms being introduced into the uterus during insertion. About
1/3 of women diagnosed with PID developed the infection within a
week of LILETTA insertion, while the remainder were diagnosed more
than six months after insertion. Counsel women who receive LILETTA
to notify a healthcare provider if they have complaints of lower
abdominal or pelvic pain, odorous discharge, unexplained bleeding,
fever, or genital lesions or sores. PID is often associated with
sexually transmitted infections (STIs); LILETTA does not protect
against STIs, including HIV. PID or endometritis may be
asymptomatic but still result in tubal damage and its sequelae.
Inform women about the possibility of PID and that PID can cause
tubal damage leading to ectopic pregnancy or infertility, or
infrequently can necessitate hysterectomy, or cause death.
Expect changes in bleeding patterns with LILETTA
Spotting and irregular or heavy bleeding may occur during the
first 3 to 6 months. Periods may become shorter and/or lighter
thereafter. Cycles may remain irregular, become infrequent, or even
cease. Consider pregnancy if menstruation does not occur within 6
weeks of the onset of previous menstruation.
If a significant change in bleeding develops during prolonged
use, take appropriate diagnostic measures to rule out endometrial
pathology.
Be aware of other serious complications and most common
adverse reactions
Some serious complications with IUSs like LILETTA are sepsis,
perforation, and expulsion. Severe infection or sepsis, including
Group A streptococcal sepsis (GAS), have been reported following
insertion of other LNG-releasing IUSs. Aseptic technique during
insertion of LILETTA is essential in order to minimize serious
infections such as GAS.
Perforation (total or partial, including penetration/embedment
of LILETTA in the uterine wall or cervix) may occur, most often
during insertion, although the perforation may not be detected
until sometime later. Perforation may reduce contraceptive
efficacy. If perforation occurs, locate and remove LILETTA. Surgery
may be required. Delayed detection or removal of LILETTA in case of
perforation may result in migration outside the uterine cavity,
adhesions, peritonitis, intestinal perforations, intestinal
obstruction, abscesses, and erosion of adjacent viscera. The risk
of perforation is higher if inserted in lactating women and
may be higher if inserted in women who are postpartum or when the
uterus is fixed retroverted.
Partial or complete expulsion of LILETTA may occur, resulting in
the loss of contraceptive protection.
Delay LILETTA insertion a minimum of 6 weeks or until uterine
involution is complete following a delivery or a second trimester
abortion. Remove a partially expelled LILETTA. If expulsion has
occurred, a new LILETTA may be inserted within 7 days after the
onset of a menstrual period after pregnancy has been ruled out.
Ovarian cysts may occur and are generally asymptomatic, but may
be accompanied by pelvic pain or dyspareunia. Evaluate persistent
ovarian cysts.
In the clinical trial of LILETTA the most common adverse
reactions (≥5% users) were vaginal infections (13.6%), vulvovaginal
infections (13.3%), acne (12.3%), headache or migraine (9.8%),
nausea or vomiting (7.9%), dyspareunia (7.0%), abdominal pain or
discomfort (6.8%), breast tenderness or pain (6.7%), pelvic
discomfort or pain (6.1%), depression or depressed mood (5.4%), and
mood changes (5.2%).
Teach patients to recognize and immediately report signs or
symptoms of the aforementioned conditions. Evaluate patients 4 to 6
weeks after insertion of LILETTA and then yearly or more often if
clinically indicated.
Please see the link to LILETTA Full Prescribing Information:
http://www.allergan.com/assets/pdf/liletta_pi
About Allergan Women's Healthcare
Allergan is a leader in women's health care that is dedicated to
developing and commercializing best-in-class pharmaceuticals to
improve the health and wellness of women. Allergan takes a holistic
and a best-in-class approach to women's healthcare as it
prioritizes educational partnerships with OB/GYNs. The mission of
Allergan Women's Healthcare extends beyond its pharmaceutical
products to ensure that all women can make informed decisions about
their health and have access to high-quality medications. Allergan
is committed to investing in programs that support the education
and well-being of all women.
About Medicines360
Medicines360, located in San
Francisco, California, is a nonprofit global women's health
pharmaceutical company with a mission to expand access to quality
medicines for all women regardless of their socioeconomic status,
insurance coverage or geographic location. Medicines360 is
committed to working with healthcare providers, advocacy groups and
patients to deliver innovative and meaningful treatments that help
women around the world have greater access to the medicines they
need. For more information, visit www.medicines360.org.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceuticals, devices
and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines our approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
For more information, visit Allergan's website at
www.Allergan.com
Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public
filings with the Securities and Exchange Commission, including
but not limited to Allergan's Annual Report on Form 10-K for the
year ended December 31, 2015 and
Quarterly Report on Form 10-Q for the quarter ended March 31, 2016 (such periodic public filings
having been filed under the "Actavis plc" name). Except as
expressly required by law, Allergan disclaims any intent or
obligation to update these forward-looking statements.
CONTACTS:
Investors:
Lisa
DeFrancesco
862.261.7152
Allergan Media:
Mark
Marmur
862.261.7558
Lisa Kim
714.246.3843
Medicines360 Media:
Shannon
Moore
415.486.3275
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SOURCE Medicines360