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Escitalopram, New Generation Selective Serotonin Reuptake Inhibitor, Promising In Major Depressive Disorder

SAN JUAN, PUERTO RICO -- December 13, 2000 -- Escitalopram, the isomer of Celexa™ (citalopram HBr) and a new generation selective serotonin reuptake inhibitor (SSRI), produced significant improvement relative to placebo at 10 mg/day and 20 mg/day doses in a Phase III clinical trial of 366 patients with major depressive disorder, reported researchers here at the American College of Neuropsychopharmacology 2000 Annual Meeting in San Juan, Puerto Rico.

Based on the clinical trial data, Forest Laboratories will submit a New Drug Application in the first half of 2001 to the U.S. Food and Drug Administration seeking an indication for escitalopram for the treatment of depression.

"Escitalopram exhibited strong efficacy at doses of 10 and 20 mg/day, which is noteworthy because no other anti-depressant is approved as effective in a general population of depressed patients at 10 mg/day," noted William Burke, MD, professor of psychiatry, University of Nebraska Medical Center and lead investigator of the escitalopram clinical trial. "The drug was well-tolerated at both daily dosages."

Citalopram is a racemic mixture with two mirror image halves, an S- and R-isomer. The S-isomer of citalopram is the active isomer in terms of its contribution to citalopram's antidepressant effects, while the R-isomer does not contribute to its antidepressant activity. With escitalopram, the R-isomer has been removed, leaving only the active S-isomer or single isomer.

In a double-blind, multicenter clincal trial, a total of 366 patients with an ongoing major depressive episode were randomized to placebo, escitalopram 10 mg/day, or escitalopram 20 mg/day and entered an eight-week double-blind treatment period. Patients in the 20 mg/day escitalopram group were titrated to their assigned dose after one week of treatment at a dose of 10 mg/day.

Both escitalopram 10 mg/day and escitalopram 20 mg/day produced significant improvement compared to placebo on all of the depression measures by the study's end. Severity of depression symptoms was evaluated with the Montgomery Asberg Depression Rating Scale (MADRS), the Hamilton Depression Rating Scale (HAMD) and the Clinical Global Impressions (CGI) scale. Significant improvement versus placebo was observed beginning at week 1 on the CGI Improvement scale and the HAMD depressed mood item and from week 2 onwards on the MADRS and HAMD. Once the significant improvement was established in week one or two, it was maintained throughout the study period.

"The magnitude of change from baseline to the study's end in the Hamilton Depression Rating Scale or HAMD was especially impressive," noted Dr. Burke.

Treatment with escitalopram in the Phase III clinical trial was well tolerated: the incidence of discontinuations for adverse events was 2.5 percent in the placebo group, 4.2 percent in the escitalopram 10 mg/day group, and 10.4 percent in the escitalopram 20 mg/day group. "Escitalopram had remarkably low discontinuance rates in our study due to its high tolerability," noted Dr. Burke.

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