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 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.
SOURCE Forest Laboratories, Inc.
CONTACT:
Frank J. Murdolo, Vice President - Investor Relations, of
Forest Laboratories, Inc., +1-212-224-6714,
or Frank.Murdolo@frx.com;
or
Patricia Li of Cohn & Wolfe,
+1-212-537-8172, or Patricia.Li@cohnwolfe.com
Web Site: http://www.frx.com
(FRX)