NEW YORK, Jun 24, 2004 /PRNewswire-FirstCall via COMTEX/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today the results of a recently completed placebo-
controlled study of Lexapro(R) (escitalopram oxalate) in children and
adolescents. Patients receiving Lexapro did not demonstrate statistically
significant separation from placebo in the primary efficacy measure, the
mean change from baseline in the Children's Depression Rating Scale-Revised
(CDRS-R) score.
The study was just completed and the safety data reported to the U.S. Food
and Drug Administration (FDA). While data from the study are still being
analyzed, initial results are being disclosed in this release.
The study found that Lexapro was well tolerated in both children and
adolescents with no significant difference in withdrawal rates due to adverse
events with Lexapro as compared to placebo. A separate analysis evaluating
the frequency of suicide-related events and worsening of depression found that
two placebo-treated patients reported suicide-related events and one placebo
patient reported worsening of depression, whereas only one Lexapro-treated
patient reported a suicide-related event and no Lexapro-treated patient
reported worsening of depression. Forest believes the results of this trial
in addition to the pediatric depression trials of citalopram (marketed as
Celexa(R) in the U.S.) show that there is no added risk of suicidality or
worsening of depression due to the use of these products in pediatric
patients. There have been no suicides observed in the pediatric placebo-
controlled clinical trial experience with either citalopram or Lexapro.
These initial analyses revealed positive trends in some of the secondary
efficacy measures for the group of patients treated with Lexapro as compared
to the placebo group.
Escitalopram is the single S-enantiomer form and therapeutically active
component of the drug citalopram. There have been two pediatric, placebo-
controlled clinical trials involving citalopram; one European trial in both
hospitalized and outpatient adolescents, and one U.S. trial in child and
adolescent outpatients.
In the European trial, citalopram did not show any improvement of
depressive symptoms versus placebo. In contrast, the U.S. pediatric
depression trial of citalopram showed a reduction of symptoms of depression to
a significantly greater extent than placebo.
"It is important to better define the role antidepressants can play in
treating this population," said Lawrence S. Olanoff, M.D., Ph.D., Executive
Vice President and Chief Scientific Officer, Forest Laboratories, Inc. "The
two U.S. studies are comparable in design and studied similar patient
populations. We recognize that the European study is limited in its
comparability to the U.S. experience due to its unique design and patient
population -- which included both hospitalized patients and outpatients, many
of whom had a history of more complicated depressive disorders. We believe
that the aggregate safety and efficacy experience with Celexa and Lexapro in
pediatric patients remains encouraging and that further study is warranted."
Forest plans to discuss with the FDA the initiation of new pediatric
studies with Lexapro in the U.S. with the goal of ultimately achieving
approval of its use in pediatric patients with major depressive disorder.
Lexapro Pediatric Study Details
Two hundred and sixty four patients, ages 6 to 17 with major depressive
disorder and a CDRS-R score of 40 or greater, participated in the randomized,
double-blind, multicenter, flexible dose study. Patients received either
Lexapro (10-20 mg/day) or placebo treatment for up to 8 weeks. The primary
efficacy measure was the mean change from baseline to week eight on the
CDRS-R score. Secondary efficacy measures included the Clinical Global
Impressions - Improvement (CGI-I) Scale, the Clinical Global Impressions -
Severity (CGI-S) Scale, and the Children's Global Assessment Scale (CGAS).
The initial results of the trial indicated that the change from baseline for
the CGAS and the CGI-S scores appeared greater for the Lexapro treated group
compared to the placebo group, however the differences did not quite achieve
statistical significance (p= 0.07 and 0.06, respectively). When these same
efficacy measures were analyzed for those subjects who remained in the study
through the eight week assessment, statistically significant (p < 0.05)
improvements were seen in the Lexapro group for both these assessments by
comparison to the placebo group.
Lexapro was well tolerated in both pediatric and adolescent groups as
compared to placebo treatment. No significant difference in drop-out rates
due to adverse events compared to placebo was observed (1.5 % for both
Lexapro-treated patients and placebo-treated patients). The incidence of
patients with adverse events, including activation side effects, was similar
between the Lexapro and placebo groups. Adverse events occurring at an
incidence of >= 10% in patients treated with Lexapro or placebo respectively,
included headache (22.9% and 21.8%), abdominal pain (10.7% and 5.3%), and
menstrual cramps (4.4% and 10.1%).
About Lexapro
Lexapro is the newest and fastest-growing selective serotonin reuptake
inhibitor (SSRI) and has been prescribed for more than 5 million patients in
the U.S.
Lexapro was approved by the U.S. Food and Drug Administration in August
2002 for both the initial and maintenance treatment of major depressive
disorder in adults and in December 2003 for the treatment of generalized
anxiety disorder in adults.
The most common adverse events reported with Lexapro (reported at rates of
approximately 5% or greater and 2 times or more the incidence seen in the
placebo group) were nausea, insomnia, ejaculation disorder, somnolence,
increased sweating, fatigue, decreased libido, and anorgasmia. Lexapro is
contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in
patients with a hypersensitivity to escitalopram oxalate or any of the
ingredients in Lexapro.
As with other SSRIs, caution is indicated in the co administration of
tricyclic antidepressants (TCAs) with Lexapro. As with other psychotropic
drugs that interfere with serotonin reuptake, patients should be cautioned
regarding the risk of bleeding associated with the concomitant use of Lexapro
with NSAIDs, aspirin, or other drugs that affect coagulation.
Patients with major depressive disorder, both adult and pediatric, may
experience worsening of their depression and/or the emergence of suicidal
ideation and behavior (suicidality), whether or not they are taking
antidepressant medications, and this risk may persist until significant
remission occurs. Although no causal role for antidepressants in inducing
such behaviors has been established, patients being treated with
antidepressants should be observed closely for clinical worsening and
suicidality, especially at the beginning of a course of drug therapy, or at
the time of dose changes, either increases or decreases.
Forest Laboratories licenses Lexapro from H. Lundbeck A/S, the Danish
pharmaceutical firm that developed escitalopram and citalopram.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: Lexapro(R), an
SSRI antidepressant indicated for the initial and maintenance treatment of
major depressive disorder and for generalized anxiety disorder; Celexa(R), an
antidepressant; Namenda(R), an N-methyl-D-aspartate (NMDA)-receptor antagonist
indicated for the treatment of moderate to severe Alzheimer's disease;
Tiazac(R), a once-daily diltiazem, indicated for the treatment of angina and
hypertension; Benicar(R),* an angiotensin receptor blocker indicated for the
treatment of hypertension; Benicar HCT(TM), an angiotensin receptor blocker
and diuretic combination product indicated for the second-line treatment of
hypertension; and Aerobid(R), an inhaled steroid indicated for the treatment
of asthma.
*Benicar(R) is a registered trademark of Sankyo Pharma, Inc.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements are subject to risks and
uncertainties that affect our business, including risk factors listed from
time to time in the Company's SEC reports, including the Company's Annual
Report on Form 10-K for the fiscal year ended March 31, 2004. Actual results
may differ materially from those projected.