Phase III Data Presented at American Psychiatric Association Annual Meeting
WASHINGTON, May 7 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that study results show Lexapro (escitalopram
oxalate) significantly improved symptoms of depression as compared to placebo
treatment and was well tolerated in adolescents, aged 12-17, with major
depressive disorder (MDD), according to phase III data presented at the 2008
Annual Meeting of the American Psychiatric Association. These results suggest
that Lexapro has potential as a useful treatment option for adolescents with
depression. Top-line results of this study were initially released in
November 2007.
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"Treating depression in adolescents can be particularly challenging
because few antidepressants have demonstrated efficacy in clinical trials in
this population," said Graham Emslie, MD, Professor of Psychiatry at the
University of Texas Southwestern Medical Center in Dallas. "In this study,
Lexapro significantly improved depressive symptoms in adolescents with MDD,
and was also well tolerated by study participants."
Researchers estimate that up to eight percent of adolescents are affected
by depression. Depression is a chronic disease that requires medical
treatment. However, FDA-approved treatment options for this population are
limited. Lexapro is not currently approved by the FDA for use in pediatric or
adolescent patients.
Based on the results of this study, Forest plans to file for an adolescent
depression indication for Lexapro this year.
Study Results
A double-blind, parallel-group, placebo-controlled phase III study to
evaluate the safety and efficacy of Lexapro in the treatment of depressed
adolescents, aged 12-17, was conducted in multiple centers across the U.S. A
total of 316 patients entered the eight week study, receiving either Lexapro
10-20 mg (n=158) or placebo (n=158). The primary endpoint was change from
baseline to Week 8 on the Children's Depression Rating Scale - Revised
(CDRS-R) using last observation carried forward (LOCF) approach. The CDRS-R
is a commonly used clinician-rated instrument that covers 17 symptom areas of
depression relevant to adolescents, including impaired schoolwork, difficulty
having fun, social withdrawal, physical complaints, and low self-esteem. The
study showed statistically significant improvement in patients treated with
Lexapro relative to placebo based on the change from baseline in the CDRS-R
score (-22.1 for Lexapro vs. -18.8 for placebo treatment; p=0.022).
The trial also showed that Lexapro was generally well-tolerated.
Discontinuation rates due to adverse events were 2.6 percent and 0.6 percent
for patients receiving Lexapro and placebo, respectively. Serious adverse
events were reported by 2.6 percent of patients receiving Lexapro and 1.3
percent for patients receiving placebo. The most commonly reported adverse
events (greater than 10 percent in either group) were headache (25 percent in
Lexapro patients vs. 26 percent with placebo), menstrual cramps (11 percent
vs. 15 percent placebo), nausea (10 percent vs. 8 percent placebo), insomnia
(10 percent vs. 6 percent placebo) and inflicted injury (9 percent vs. 13
percent placebo), the majority of which were accidental in nature. The only
adverse event occurring at a frequency of greater than or equal to 5 percent
and with an incidence for Lexapro treated patients twice that of placebo
treated patients was influenza-like symptoms (7 percent vs. 3 percent
placebo).
Depression and Adolescents
Adolescent depression is characterized by persistent sadness and loss of
interest in usual activities. While the brain chemistry of depression is not
fully understood, research suggests that depression is caused by an imbalance
of certain chemicals in the brain, most notably serotonin.
Despite advances and progress in identifying and treating mental disorders
in adolescents, depression in this population remains under-treated.
Depression is a chronic disease that requires medical attention and treatment,
and if left untreated, may have serious consequences. According to the
National Alliance on Mental Illness (NAMI), adolescents with untreated
depression are likely to have ongoing problems in school, at home and with
their friends.
For adolescents who suffer from depression, psychotherapy,
cognitive-behavior therapy, interpersonal therapy and medication 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 an SSRI being studied as a treatment for adolescents with MDD.
Lexapro is indicated for the initial and maintenance treatment of major
depressive disorder and 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
believed to influence mood. In adults, Lexapro 10 mg/day is a well-tolerated
therapy, with drop-out rates due to adverse events comparable to placebo
treatment in depression trials. Lexapro has been prescribed to over 16
million people.
Important Lexapro Information
Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Antidepressants increased
the risk of suicidality (suicidal thinking and behavior) in children,
adolescents, and young adults in short-term studies of major depressive
disorder (MDD) and other psychiatric disorders. Anyone considering the use of
antidepressants in children, adolescents or young adults must balance the risk
to clinical need. Patients of all ages started on antidepressant therapy
should be closely monitored and observed for clinical worsening, suicidality
or unusual changes in behavior, especially at the beginning of therapy or at
the time 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.
Lexapro is contraindicated in patients taking monoamine oxidase inhibitors
(MAOIs), pimozide (see DRUG INTERACTIONS - Pimozide and Celexa), or in
patients with hypersensitivity to escitalopram oxalate. As with other SSRIs,
caution is indicated in the coadministration of tricyclic antidepressants
(TCAs) with Lexapro. SSRIs and SNRIs (including Lexapro) and other
psychotropic drugs that interfere with serotonin reuptake may increase the
risk of bleeding events. Concomitant use of aspirin, NSAIDs, warfarin and
other anticoagulants may add to the risk. Patients should be cautioned about
these risks. SSRIs and SNRIs have been associated with clinically significant
hyponatremia. Elderly patients or patients taking antidiuretics 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 most common
adverse events with Lexapro versus placebo (approximately 5 percent or greater
and approximately twice that of placebo) were nausea, insomnia, ejaculation
disorder, somnolence, increased sweating, fatigue, decreased libido, and
anorgasmia. Further information on Lexapro is provided in the FDA approved
Package Insert.
About Forest Laboratories and Its Products
Forest Laboratories is a US-based pharmaceutical company dedicated to
identifying, developing, and delivering products that make a positive
difference in people's lives. Forest Laboratories' growing product line
includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for
the initial and maintenance treatment of major depressive disorder and
generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl-D-
aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; Campral(R)* (acamprosate calcium), indicated in
combination with psychosocial support for the maintenance of abstinence from
alcohol in patients with alcohol dependence who are abstinent at treatment
initiation; and Bystolic(TM) (nebivolol), a beta-adrenergic receptor blocking
agent indicated for the treatment of hypertension. In addition to our growing
product line, Forest also co-promotes the Daiichi Sankyo, Inc. product
Azor(TM)* (amlodipine and olmesartan medoxomil), a calcium channel blocker and
angiotensin receptor blocker combination product indicated for the treatment
of hypertension. For more information, visit www.frx.com.
* Azor is a trademark of Daiichi Sankyo, Inc. and Campral is a registered
trademark of Merck Sante s.a.s., a subsidiary of Merck KGaA, Darmstadt,
Germany.
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 the Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings.
SOURCE Forest Laboratories, Inc.
-0- 05/07/2008
/CONTACT: Charles E. Triano, Vice President, Investor Relations, Forest
Laboratories, Inc., +1-212-224-6714, Charles.Triano@frx.com; or Patricia Li,
Cohn & Wolfe, +1-212-798-9772 office, or +1-973-632-3249 cell,
Patricia_Li@nyc.cohnwolfe.com, for Forest Laboratories/
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/Web site: http://www.frx.com /
(FRX)
CO: Forest Laboratories, Inc.; American Psychiatric Association
ST: District of Columbia
IN: MTC HEA
SU: CHI TRI TDS
KM-AP
-- NYW091 --
0766 05/07/2008 12:00 EDT http://www.prnewswire.com