Lexapro(R) Demonstrated Significance on Prospectively Defined Efficacy Parameter and Was Better Tolerated Than Cymbalta(R) in Tr
December 06 2006 - 8:00AM
PR Newswire (US)
Higher Response and Study Completion Rates Among Patients Receiving
Lexapro NEW YORK, Dec. 6 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc., (NYSE:FRX) today announced the results of a new
study demonstrating that Lexapro (escitalopram oxalate) provided a
greater reduction in MADRS scores, (p=0.040), utilizing an LOCF
approach and was better tolerated than Cymbalta (duloxetine), based
on the percentage of patients discontinuing treatment due to
adverse events, in the treatment of patients with moderate to
severe major depressive disorder (MDD). (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) Dr. Arif
Kahn, Medical Director of Northwest Clinical Research Center and
investigator in this study said, "These findings add to a number of
studies that demonstrate the clinical value of Lexapro in the
treatment of depression." Study details Patients (aged 18-80 years)
with DSM-IV diagnosed MDD as determined by a Montgomery-Asberg
Depression Rating Scale (MADRS) score of 26 or greater were
randomized to eight weeks of double-blind treatment with Lexapro
10-20 mg/day (dose fixed at 10 mg/day for the first four weeks with
optional up-titration to 20 mg/day thereafter) or Cymbalta 60
mg/day. Dosing of the two antidepressants was consistent with
information in the FDA-approved package inserts of both drugs. The
primary, prospectively-defined, efficacy endpoint was the change
from baseline at week eight in the MADRS total score, using the
last observation carried forward (LOCF) approach. At the start of
the study, 137 patients were enrolled in the Lexapro arm of the
study and 133 in the Cymbalta arm. At the end of the eight-week
study, Lexapro patients demonstrated greater improvement than
Cymbalta patients in total MADRS score (LSMD, least squared mean
difference, -2.42 [95% CI: -4.73, -0.11]; p=0.040). The proportion
of patients responding to Lexapro treatment, as determined by a 50
percent improvement in MADRS total score, also was greater when
compared to patients in the Cymbalta group (68 percent vs 52
percent, p=0.011; LOCF). Remission rates were 44 percent in the
Lexapro group and 38 percent in the Cymbalta group, as determined
by a total MADRS score of 10 or less, this difference was not
significant. The rate of improvement on the MADRS was similar
between the groups when an observed cases analysis was conducted.
In addition, there was no difference seen between the group on a
number of measures of relief of somatic and pain-related symptoms.
More patients in the Lexapro group completed eight weeks of
treatment than patients in the Cymbalta group (87 percent vs 69
percent, p=0.001), and fewer patients receiving Lexapro
discontinued treatment due to adverse events compared to patients
receiving Cymbalta (2 percent vs 13 percent, p=0.001). About
Lexapro Lexapro is a selective serotonin reuptake inhibitor (SSRI)
that has been prescribed for more than 14 million adult patients in
the United States. 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 (MDD) in adults, and in
December 2003 for the treatment of Generalized Anxiety Disorder
(GAD) in adults. The most common adverse events reported with
Lexapro (reported at rates of approximately 5 percent 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), pimozide, 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 coadministration 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 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. 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. 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 (http://www.frx.com/) is a US-based
pharmaceutical company dedicated to identifying, developing, and
delivering products that make a positive difference in peoples'
lives. Forest Laboratories' growing product line includes
Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for
the internal 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; Benicar(R)*
(olmesartan medoxomil), an angiotensin receptor blocker, and
Benicar* HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an
angiotenisn receptor blocker and diuretic combination product, each
indicated for the treatment of hypertension; and 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.
* Benicar is a registered trademark of Daiichi Sankyo, Inc., and
Campral is a registered trademark of Merck Sante s.a.s., 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'
SEC reports, including the Company's Annual Report on Form 10-K for
the fiscal year ended March 31, 2006 and on Form 10-Q for the
periods ended June 30 and September 30, 2006.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc. CONTACT: Charles E. Triano, VP, Investor
Relations, of Forest Laboratories, Inc., +1-212 224-6714, or Web
site: http://www.frx.com/
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