DUBLIN and SAN FRANCISCO, Sept.
14, 2016 /PRNewswire/ -- Allergan plc, (NYSE: AGN) a leading
global pharmaceutical company, and Medicines360, a nonprofit global
women's health pharmaceutical company, today announced the launch
of the new LILETTA® (levonorgestrel-releasing
intrauterine system) 52 mg IUD single-handed inserter (intrauterine
device), for use by women to prevent pregnancy for up to three
years. The launch and availability of the single-handed
inserter follows the U.S. Food and Drug Administration (FDA)
approval received in January
2016.
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"As a leader in women's healthcare, Allergan is committed to
providing our customers with the most efficient technology and
support needed to educate their patients about their reproductive
health," said David Nicholson, PhD,
Chief R&D Officer at Allergan. "The launch of the LILETTA
single-handed inserter continues to demonstrate our commitment to
innovation in women's health and serves as another bold example of
providing options to better serve our customers and patients."
"We are excited to bring to market the new LILETTA inserter and
anticipate that the single-handed process may lead to broader use
by healthcare providers, thereby increasing the number of women who
have access to this effective contraceptive," said Jessica Grossman, MD, CEO of Medicines360.
"Specifically, the new LILETTA inserter includes an ergonomic
design allowing for single-handed insertion that can be used with
either hand; a bendable tube to accommodate the anatomy of the
patient during insertion; and the ability to reload the device if
needed before insertion."
A comprehensive product demonstration program is being
implemented by Allergan and Medicines360 to help inform clinicians
in the private and public sectors about the new
inserter.
The approval of the new single-handed inserter was based on the
largest hormonal IUD trial, ACCESS IUS (A Comprehensive
Contraceptive Efficacy & Safety Study of an IUS), conducted in
the U.S. with 1,751 enrolled women receiving LILETTA, the same
trial that supported the initial approval of LILETTA. LILETTA was
shown to be safe and effective for a broad range of women, with a
cumulative three-year efficacy rate of 99.45 percent. LILETTA
is indicated for women regardless of parity or Body Mass Index
(BMI) and can be inserted on the same day she visits the clinic,
providing that she is not pregnant. During the ACCESS IUS clinical
trial, the success rate for insertions with the new single-handed
inserter was 99.2%.
LILETTA is a hormone-releasing system placed in a woman's uterus
to prevent pregnancy for up to three years and is greater than 99%
effective. LILETTA is not permanent, it can be removed at any time
by a healthcare provider, offering the flexibility of use for
either long- or short-term contraception. LILETTA can be used in
women regardless of whether or not they've birthed a child.
Allergan initially launched LILETTA in partnership with
Medicines360, a non-profit global pharmaceutical company whose
mission is to provide access to medicines for women regardless of
their socioeconomic status, insurance status, or geographic
location. The new LILETTA single-handed inserter with an optimized
package received approval in May
2016, and will succeed the two-handed inserter, which was
approved by the U.S. FDA in February, 2015.
LILETTA systems with the single-handed inserter will be
available in the U.S. commercially as well as at a lower cost to
public health clinics enrolled in the 340B Drug Pricing
Program.
ABOUT LILETTA
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 (eg, 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 (eg, 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.
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 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
65+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 15,000 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
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.
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:
Amanda
Breeding
(415) 229-7649
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SOURCE Allergan plc