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).
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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.
SOURCE Forest Laboratories, Inc.
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Related links:
http://www.frx.com/
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
CONTACT:
Charles E. Triano, VP, Investor Relations, of
Forest Laboratories, Inc., +1-212 224-6714, or
Charles.Triano@FRX.com
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