NEW YORK, Sept. 19 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today the results of an eight-week study performed in
the United States, which found that Lexapro(TM) (escitalopram oxalate)
relieves the symptoms of major depressive disorder and helps patients achieve
remission as effectively as Effexor(R) XR. In addition, Lexapro was
significantly better tolerated than Effexor XR, with four times as many
patients in the Effexor XR group discontinuing the study due to side effects.
This is the first study to demonstrate comparable remission rates between a
selective serotonin reuptake inhibitor (SSRI) and Effexor XR. The findings
were presented at a global meeting of neuropsychopharmacologists in Prague,
Czech Republic.
"While Lexapro and Effexor XR are effective in treating depression, the
challenge is to find a treatment that is also well tolerated to ensure patient
compliance," said lead investigator of the study and former Professor of
Psychiatry at Michigan State University, Robert Bielski, M.D. "These results
suggest that Lexapro may be a better treatment option due to its favorable
side-effect profile."
Lexapro is the newest member of a class of antidepressants known as SSRIs,
and Effexor XR is in a class known as serotonin-norepinephrine reuptake
inhibitors (SNRIs). In this study, patients were administered the highest
recommended doses for each medication in the United States.
Study Details
One hundred ninety-five patients with major depressive disorder (baseline
Hamilton Rating Scale For Depression [HAM-D] score greater than or equal to
20 and a Montgomery-Asberg Depression Rating Scale [MADRS] score indicative of
moderate-to-severe depression) were randomized to receive either Lexapro
(N=97) or Effexor XR (N=98) in the eight-week, double-blind, fixed-dose trial.
Following one week of single-blind placebo treatment, patients were titrated
to either 20 mg per day of Lexapro or 225 mg per day of Effexor XR.
The primary efficacy variable was the mean change from baseline to week
eight in the MADRS scores. Remission was defined as a MADRS score less than
or equal to 10. Response was defined as at least a 50 percent reduction from
baseline MADRS scores.
Remission rates at week eight were similar in the Lexapro group
(41.2 percent) and in the Effexor XR group (36.7 percent). At the conclusion
of the study, 58.8 percent of Lexapro-treated patients were considered
responders compared to 48 percent of Effexor XR-treated patients. Mean
changes in MADRS scores from baseline to endpoint were -15.9 and -13.6 for the
Lexapro and Effexor XR groups, respectively.
Tolerability measures consistently favored Lexapro over Effexor XR during
the study. Patients treated with Lexapro (68.4 percent) experienced fewer
adverse events than patients treated with Effexor XR (85 percent).
Moreover, only 4.1 percent of patients in the Lexapro group prematurely
withdrew from the study due to adverse events compared to 16 percent of
patients in the Effexor XR group. Adverse events occurring at an incidence of
> 10 percent with Lexapro or Effexor XR, respectively, included nausea (6.1%
and 24%), increased sweating (5.1% and 11%), somnolence (9.2% and 17%), dry
mouth (12.2% and 16%), headache (15.3% and 14%), and ejaculation disorder
(6.7% and 22.6%).
About Lexapro
Lexapro is the newest and fastest-growing selective serotonin reuptake
inhibitor (SSRI). Lexapro was developed by isolating the therapeutically
active portion of the antidepressant Celexa(TM) (citalopram HBr).
Lexapro was approved by the U.S. Food and Drug Administration (FDA) in
August 2002 for both the initial and maintenance treatment of major depressive
disorder. Lexapro is available as tablets and oral solution.
As with all SSRIs, Lexapro should not be taken together with monoamine
oxidase inhibitors (MAOI). For more information about Lexapro, please visit
www.lexapro.com.
Forest Laboratories licenses Lexapro from the Danish pharmaceutical firm
H. Lundbeck A/S, which developed escitalopram and citalopram.
Except for historical information contained herein, this release contains
"forward-looking statements" within the meaning of the Private Securities
Litigation 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, 2003. Actual results
may differ materially from those projected.