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Back To Vidyya Next Generation SSRIs Successfully Complete Phase III Clinical Trial

Researcher Report From The American College Of Neuropsychopharmacology 2000 Annual Meeting

Escitalopram, an isomer of Celexatm (citalopram HBr) and a more potent and 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 today at the American College of Neuropsychopharmacology 2000 Annual Meeting in San Juan, Puerto Rico.

Based on these Phase III clinical trial results, 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 the treatment of depression for escitalopram.

"We are extremely pleased with the robust results of escitalopram in this Phase III clinical trial," said Howard Solomon, Chairman and Chief Executive Officer, Forest Laboratories. "Escitalopram, the single isomer of Celexa, has been demonstrated in numerous animal and laboratory studies to be at least twice as potent as its parent compound in terms of antidepressant activity. We are pleased that the results of this clinical trial confirm the unequivocal antidepressant activity of escitalopram in patients."

Citalopram or Celexa is the fastest-growing anti-depressant in the United States and is the top-selling antidepressant in 13 countries in which three or more SSRIs are available. The U.S. market for antidepressants, which is one of the fastest growing therapeutic categories, topped $7 billion in 1999.

An Isomer of Citalopram

Citalopram is a racemic mixture with two mirror image halves called the S- and R-isomers. 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 a single isomer.

Phase III Clinical Trial Details

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 8-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 the clinical measures of depression. 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. "Escitalopram exhibited strong efficacy versus placebo 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 magnitude of change for escitalopram versus placebo from baseline to study endpoint on the Hamilton Depression Rating Scale was especially impressive," noted Dr. Burke. "An equally robust finding was observed on the MADRS scale."

Treatment with escitalopram in the Phase III clinical trial was well tolerated: the incidence of discontinuations for adverse events was 2.5% in the placebo group, 4.2% in the escitalopram 10 mg/day group, and 10.4% 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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Editor: Susan K. Boyer, RN
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