Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents
March 20 2009 - 1:38PM
PR Newswire (US)
NEW YORK, March 20, 2009 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. (NYSE:FRX) today announced that the U.S. Food
and Drug Administration (FDA) has approved the Company's
supplemental New Drug Application (sNDA) for Lexapro (escitalopram
oxalate) for the acute and maintenance treatment of Major
Depressive Disorder (MDD) in adolescents, 12 - 17 years of age.
Lexapro is only the second antidepressant to be approved for the
treatment of MDD in adolescents, a medical condition that affects
approximately 2 million adolescents in the U.S. (LOGO:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO) "Major
depressive disorder in adolescents is a debilitating, but treatable
illness," said Howard Solomon, Chairman and Chief Executive
Officer, of Forest. "We have long believed that Lexapro would be of
benefit for the treatment of depression in adolescents and that is
why we undertook the several studies described in the package
insert. We are enormously gratified that Lexapro will be available
for depressed adolescents who so much require the benefits which
Lexapro has made available for depressed adults for the past seven
years." Study Results The approval of Lexapro for the treatment of
adolescent depression was supported by two placebo-controlled
studies, one conducted in adolescent patients taking Lexapro and
one conducted in children and adolescents taking citalopram. In an
8-week flexible- dose, placebo-controlled study that compared
Lexapro 10-20 mg/day to placebo in 12 to 17 year old patients
reported in 2008, Lexapro showed statistically significant greater
mean improvement from baseline, compared to placebo, on the
Children's Depression Rating Scale-Revised (CDRS-R). In another
8-week, flexible-dose, placebo-controlled study, children and
adolescents 7 to 17 years of age treated with racemic citalopram
20-40 mg/day showed statistically significant greater mean
improvement from baseline on the CDRS-R compared to patients
treated with placebo. The positive results for this trial largely
came from the adolescent subgroup. The FDA's determination of the
efficacy of Lexapro in the acute treatment of MDD in adolescents
was established, in part, on the basis of extrapolation from this
study. Two additional flexible-dose, placebo-controlled MDD studies
were conducted: one Lexapro study in patients ages 7 to 17 and one
citalopram study in adolescents. Neither study demonstrated
efficacy on the primary efficacy parameter. Although maintenance
efficacy in adolescent patients has not been systematically
evaluated, the FDA in its review concluded that maintenance
efficacy can be extrapolated from adult data along with comparisons
of escitalopram pharmacokinetic parameters in adults and adolescent
patients. Lexapro was generally well tolerated. The overall profile
of adverse reactions in pediatric patients was generally similar to
that seen in adult studies and is described in the package insert.
"Adolescent depression can often be challenging to treat because
there are limited treatment options that are proven to be effective
and well-tolerated in this patient population," said Graham Emslie,
MD, Professor of Psychiatry at the University of Texas Southwestern
Medical Center in Dallas. "The FDA approval of Lexapro for
adolescents is a significant development for the patients who
struggle with this illness every day. Depression and Adolescents
Depression in adolescents, as in adults, is a serious disease that
requires medical treatment. Approximately 2 million U.S.
adolescents aged 12 to 17 have suffered a serious bout of
depression in the past year, according to a recent national survey
conducted by the Substance Abuse and Mental Health Services
Administration. Adolescent depression is characterized by
persistent sadness or irritability or loss of interest in usual
activities. For adolescents who suffer from depression, talk
therapy and medication can play an important role in the management
of their illness. Patients on antidepressant treatment should also
be closely monitored by healthcare providers, family members, and
other caregivers. About Lexapro Lexapro is indicated for the acute
and maintenance treatment of MDD in adults and adolescents (aged
12-17) and for acute treatment of Generalized Anxiety Disorder
(GAD) in adults. Lexapro is thought to work by helping to restore
the brain's chemical balance. It is believed to increase the
availability of serotonin, a substance in the brain thought to
influence mood. Since its launch in 2002, Lexapro has been
prescribed to more than 18 million patients in the U.S. IMPORTANT
SAFETY INFORMATION Antidepressants increased the risk compared to
placebo of suicidal thinking and behavior (suicidality) in
children, adolescents, and young adults in short-term studies of
major depressive disorder (MDD) and other psychiatric disorders.
Anyone considering the use of Lexapro or any other antidepressant
in a child, adolescent or young adult must balance this risk with
the clinical need. Short-term studies did not show an increase in
the risk of suicidality with antidepressants compared to placebo in
adults beyond age 24; there was a reduction in risk with
antidepressants compared to placebo in adults aged 65 and older.
Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Patients of all
ages who are started on antidepressant therapy should be monitored
appropriately and observed closely for clinical worsening,
suicidality, or unusual changes in behavior, especially during the
initial few months of therapy or at times of dose changes. This
risk may persist until significant remission occurs. Families and
caregivers should be advised of the need for close observation and
communication with the prescriber. Lexapro is not approved for use
in pediatric patients less than 12 years of age. Lexapro is
contraindicated in patients taking monoamine oxidase inhibitors
(MAOIs), pimozide, or in patients with hypersensitivity to
escitalopram or citalopram. As with other SSRIs, caution is
indicated in the coadministration of tricyclic antidepressants
(TCAs) with Lexapro. SSRIs and SNRIs (including Lexapro) may
increase the risk of bleeding events. Patients should be cautioned
that concomitant use of aspirin, NSAIDs, warfarin and other
anticoagulants may add to the risk. Lexapro is not approved for use
in treating bipolar depression. Prior to initiating treatment with
an antidepressant, patients with depressive symptoms should be
adequately screened to determine if they are at risk for bipolar
disorder. Lexapro should be used cautiously in patients with a
history of mania or with a history of seizure disorder. Lexapro
should be used with caution in patients with severe renal
impairment or with diseases or conditions that produce altered
metabolism or hemodynamic responses. SSRIs and SNRIs have been
associated with clinically significant hyponatremia. Elderly
patients or patients taking diuretics or who are otherwise
volume-depleted appear to be at a greater risk. Discontinuation of
Lexapro should be considered in patients with symptomatic
hyponatremia and appropriate medical intervention should be
instituted. The concomitant use of Lexapro with other SSRIs, SNRIs,
triptans, tryptophan, antipsychotics or other dopamine antagonists
is not recommended due to the potential for development of
life-threatening serotonin syndrome or neuroleptic malignant
syndrome (NMS)-like reactions. The management of these events
should include immediate discontinuation of Lexapro and the
concomitant agent and continued monitoring. Patients should be
cautioned about operating hazardous machinery, including
automobiles, until they are reasonably certain that Lexapro therapy
does not affect their ability to engage in such activities. For
pregnant and nursing mothers, Lexapro should be used only if the
potential benefit justifies the potential risk to the fetus or
child. Patients should be monitored for adverse reactions when
discontinuing treatment with Lexapro. A gradual reduction in the
dose rather than abrupt cessation is recommended whenever possible.
The most common adverse reactions in adults treated with Lexapro
(approximately 5% or greater and at least twice the incidence of
placebo) are nausea, insomnia, ejaculation disorder, fatigue and
somnolence, increased sweating, decreased libido, and anorgasmia.
The overall profile of adverse reactions in pediatric patients was
generally similar to that seen in adult studies and is described in
the package insert. Other adverse reactions that were reported in
the pediatric trials at an incidence of at least 2% for Lexapro
treated patients and greater than that in the placebo treated
patients were back pain, urinary tract infection, vomiting, and
nasal congestion. About Forest Laboratories Forest Laboratories
(NYSE:FRX) is a U.S.-based pharmaceutical company with a long track
record of building partnerships and developing and marketing
products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of
the central nervous and cardiovascular systems, Forest's current
pipeline includes product candidates in all stages of development
and across a wide range of therapeutic areas. The company is
headquartered in New York, NY. To learn more about Forest
Laboratories, visit http://www.frx.com/. Except for the historical
information contained herein, this release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical
products, the impact of competitive products and pricing, the
timely development and launch of new products, and the risk factors
listed from time to time in Forest Laboratories' Annual Report on
Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC
filings. http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Frank J. Murdolo, Vice President - Investor Relations, of
Forest Laboratories, Inc., +1-212-224-6714, or ; or Patricia Li of
Cohn & Wolfe, +1-212-537-8172, or Web Site: http://www.frx.com/
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