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 (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.
12/06/2006
CONTACT: Charles E. Triano, VP, Investor Relations, of Forest
Laboratories, Inc., +1-212 224-6714, or Charles.Triano@FRX.com
0815 12/06/2006 08:00 EST http://www.prnewswire.com