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Celexa (Citalopram Hbr), Escitalopram Show Significant Benefit In Major Depressive Disorder; Celexa May Help Children As Well

NEW YORK, NY -- December 13, 2001 -- Forest Laboratories, Inc. announced that clinical study results were presented at an annual meeting of neuropsychopharmacologists, including a trial demonstrating that escitalopram helps prevent the relapse of depressive episodes when used as maintenance therapy.

Other research presented at the meeting included: a pooled analysis of flexible-dose studies demonstrating that patients with major depressive disorder treated with either escitalopram or Celexa™ (citalopram HBr) showed significantly greater improvement than patients receiving placebo, and a study demonstrating that Celexa may significantly reduce depression in adolescents and children.

Celexa, a selective serotonin reuptake inhibitor (SSRI) for the treatment of depression marketed by Forest Laboratories, is the fastest growing SSRI in the United States. Escitalopram, a single isomer derived from Celexa, is an investigational SSRI for depression and other disorders. Forest submitted a New Drug Application for escitalopram to the U.S. Food and Drug Administration earlier this year. Escitalopram will be marketed by Forest Laboratories in the U.S. under the trade name Lexapro™.

"Forest is committed to the development of effective medications for the treatment of depression, and the results of these studies are especially encouraging," said Howard Solomon, chairman and chief executive officer, Forest Laboratories.

In a study of patients with major depressive disorder aged 18 to 81 years, fewer patients treated with escitalopram relapsed and their time to relapse was significantly longer than those receiving placebo. The risk of relapse was shown to be 44 percent lower in patients treated with escitalopram than in those treated with placebo. Escitalopram-treated patients also exhibited significantly fewer symptoms of depression during the double-blind phase than those patients who received placebo.

"Individuals with depression face the possibility of relapsing and experiencing another depressive episode, even after achieving initial success with antidepressant treatment," said Mark Rapaport, M.D., associate professor at the University of California San Diego School of Medicine and the study's lead investigator. "This study demonstrates that escitalopram can effectively reduce the risk of relapse after an initial response to treatment, allowing people with depression to lead more productive lives."

The study began with an initial eight-week, flexible-dose, open-label treatment phase with escitalopram. Escitalopram was flexibly dosed between 10 mg and 20 mg per day during this open-label phase. Patients who were classified as responders were then randomly assigned to 36 weeks of double-blind, fixed-dose treatment. Of the 274 patients in the fixed-dose treatment phase, 181 patients received escitalopram, and 93 patients received placebo. Patients received the same dose of escitalopram during the fixed- dose phase as they had received at the end of the open-label phase. The primary efficacy variable was time to depression relapse from the start of the double-blind treatment phase.

A pooled analysis of two earlier randomized, double-blind, flexible-dose, placebo-controlled studies with a total of 844 patients showed that patients with major depressive disorder who were treated with either escitalopram or Celexa showed significantly greater improvement than depressed patients receiving placebo. Dosing of escitalopram and Celexa was adjusted as needed at specified intervals during the eight-week studies. Escitalopram was dosed at 10 mg or 20 mg per day, with a mean daily dose of 12.6 mg throughout the studies; Celexa was dosed at either 20 mg or 40 mg per day with a mean daily dose of 25.5 mg throughout the studies. The analysis showed that escitalopram and Celexa were both statistically superior to placebo on all efficacy measures. However, this superiority was demonstrated by escitalopram in the first week of treatment and later in the study by Celexa.

In both studies, escitalopram was well tolerated, with some patients experiencing adverse events including headache, nausea, diarrhea, and insomnia. Similar to previously reported studies, escitalopram discontinuation rates due to adverse events were comparable to placebo.

Celexa was shown to reduce symptoms of depression in adolescents and children with major depressive disorder to a significantly greater extent than placebo in a randomized, double-blind, placebo-controlled, flexible-dose study of 174 pediatric patients (83 children and 91 adolescents). Thirty-six percent of patients treated with Celexa for eight weeks demonstrated a reduction in depressive symptoms compared to 24 percent in the placebo group. Symptoms of depression in the Celexa group began to decrease significantly in the first week of the study and continued to decrease throughout the study.

The study also showed that Celexa was well tolerated. The primary outcome measure was the Children's Depression Rating Scale-Revised (CDRS-R), a standard diagnostic tool.

"This study is significant because few studies involving any antidepressant have shown efficacy compared to placebo in the treatment of depression in children and adolescents," said Karen Dineen Wagner, MD, PhD, Department of Psychiatry and Behavioral Sciences, University of Texas Medical Branch at Galveston, and the study's lead author. "Citalopram is now one of the few therapies for which we have data showing safety and efficacy for this population."

Children in the study were seven to 11 years old, and adolescents 12 to 17 years old. All patients in the treatment arm were given 20 mg per day of Celexa at the start of the study. Investigators had the option to increase the dose to 40 mg per day any time after the fourth week. The mean daily dose of Celexa in the final week of the study was 23.3 mg for children and 24.4 mg for adolescents. The rate of discontinuation due to adverse events was comparable in the Celexa and placebo groups (5.6 percent vs. 5.9 percent), suggesting that Celexa doses of 20 to 40 mg per day were well tolerated by the children and adolescents in the study. The more common side effects associated with use of Celexa were nausea, influenza-like symptoms, and rhinitis.

Celexa is indicated for the treatment of depression in adults over the age of 18. Currently, there are no therapies approved for the treatment of major depressive disorders in the pediatric population. The American Academy of Child and Adolescent Psychiatry estimates that 5 percent of the pediatric population -- or 3.4 million children and adolescents under the age of 18 -- suffer from depression.

Celexa is currently indicated for the treatment of depression in adults aged 18 and older. Prescribed for more than six million U.S. patients, Celexa is the fastest growing antidepressant in the U.S. Celexa is marketed by Forest Laboratories in the U.S. Celexa has been well tolerated by patients in many large-scale clinical trials. The most frequent side effects reported were nausea, dry mouth, drowsiness, insomnia, increased sweating, tremor, diarrhea, and problems with ejaculation.

SOURCE Forest Laboratories, Inc.

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