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Lexapro (Escitalopram) Significantly More Effective Than Placebo in Social/Generalized Anxiety and Panic Disorders: Presented at ADAA

NEW YORK, NY -- March 22, 2002 -- Forest Laboratories, Inc. announced that clinical study results were presented March 20^th at the annual meeting of the Anxiety Disorders Association of America (ADAA), including a trial demonstrating that Lexapro™ (escitalopram oxalate) significantly reduced anxiety in patients with generalized anxiety disorder (GAD) when compared to placebo.

Other research presented at the meeting included a study demonstrating that, when compared to placebo, Lexapro significantly reduced panic symptoms in patients with panic disorder, including panic attack frequency and severity, and a study showing that Lexapro significantly improved symptoms in patients with social anxiety disorder (SAD) as compared to placebo. Lexapro, the single-active isomer of Celexa™ (citalopram HBr), is an investigational selective serotonin reuptake inhibitor (SSRI).

Forest submitted a new drug application to the Food and Drug Administration (FDA) in March, 2001, requesting approval to market Lexapro as a treatment for major depressive disorder, and Forest recently received an approvable letter from the FDA. Forest expects that the launch of Lexapro as a treatment for major depressive disorder, which is still subject to final FDA approval, will occur in mid-2002. In addition, the data presented at the ADAA meeting on generalized anxiety disorder, panic disorder and social anxiety disorder may be used to seek future indications.

Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories, said, "In addition to our submission for major depressive disorder, Forest is committed to investigating Lexapro's full potential, and the studies presented at ADAA are extremely encouraging."

At the ADAA meeting, Duke University researchers presented clinical study results that showed Lexapro significantly reduced anxiety symptoms in patients with generalized anxiety disorder when compared to placebo. In the double-blind, placebo-controlled study, 240 patients with GAD were randomized to two treatment arms: placebo group or a Lexapro flexible-dose group for eight weeks following a one-week, single-blind placebo lead-in period. Patients were 18 to 80 years of age.

Lexapro significantly improved anxiety symptoms relative to placebo treatment, as measured by the primary evaluation tool, Hamilton Anxiety Scale (HAMA). Secondary evaluation tools, which also showed significant improvement by Lexapro, included the Clinical Global Impressions Scale (CGI), the Hospital Anxiety Depression Scale (HAD), and the Quality of Life Questionnaire.

Patients treated with Lexapro also reported their quality of life had significantly improved. In the study, Lexapro was well tolerated; the most common adverse events reported in Lexapro patients were headache, nausea and insomnia.

Generalized anxiety disorder is characterized by excessive anxiety and worry, occurring more days than not for at least six months, about various events or activities such as work or school performance.

Researchers from the University of California, San Diego, presented study results at the ADAA meeting that showed that, when compared to placebo, Lexapro significantly reduced panic disorder symptoms such as panic attack frequency and severity as well as anticipatory anxiety and phobic avoidance.

In the randomized, double-blind, placebo-controlled, multicenter study, 247 patients received either placebo or a flexible-dose of Lexapro for 10 weeks following a two-week, single-blind, placebo lead-in period. Study participants, ranging in age from 18 to 80 years old, had been diagnosed with panic disorder with or without agoraphobia.

Additionally, Lexapro-treated patients experienced a significant improvement in their overall status and quality of life as measured by the Modified Sheehan Panic and Anticipatory Anxiety Scale, the Panic and Agoraphobia Scale, the Hamilton Anxiety Scale, Clinical and Global Impressions Scale, Patient Global Evaluation, and the Quality of Life Questionnaire. In the study, Lexapro was well tolerated; the rate of discontinuation due to adverse events was comparable in both the Lexapro and placebo groups. The most common adverse events reported by Lexapro-treated patients were headache, nausea and insomnia.

Panic disorder is an anxiety disorder characterized by panic attacks, which are brief episodes of intense fear accompanied by multiple physical symptoms. These "attacks" happen repeatedly and unexpectedly in the absence of any external threat or other mental disorder. About 2.4 million American adults between the ages of 18 and 54 have panic disorder in any given year. Women are also twice as likely to suffer from panic disorder as men. Panic disorder can occur with other anxiety disorders, depressive disorders, or substance abuse.

Finally, in another study presented at the ADAA meeting, Austrian researchers from the University Hospital of Vienna reported that Lexapro demonstrated a significant improvement relative to placebo in a clinical trial of patients with social anxiety disorder.

Following a one-week, single-blind placebo lead-in period, 358 patients with social anxiety disorder were randomized to 12 weeks of double-blind, flexible-dose treatment with Lexapro or placebo. With flexible dosing, patients treated with Lexapro could be titrated to an increased dosage, after four, six or eight weeks of treatment, if needed. Lexapro was well tolerated by patients in the study. The most common adverse events reported by Lexapro-treated patients were headache, nausea and insomnia.

Based on the primary measurement tool, the Liebowitz Social Anxiety Scale (LSAS), which measures a patient's level of fear and avoidance of performance and/or social situations, Lexapro-treated patients showed a significant improvement relative to placebo. Secondary assessments, including the Clinical Global Impressions scale (CGI-S, CGI-I), which indicates a patient's severity and improvement of symptoms, as well as two of three items on the Sheehan Disability Scale (SDS), which indicate how the patient handles basic everyday life activities, such as work and family life, also showed a significantly better therapeutic effect for Lexapro compared to placebo treatment.

Social phobia is the third most common psychiatric disorder in the United States, after depression and alcohol dependency. It affects about 5.3 million Americans, or about 3.7 percent of people ages 18-54.

Lexapro is the product of a relatively new approach that involves the removal of one of two enantiomers from Celexa to create a single-enantiomer drug. Celexa is a racemic mixture with two mirror-image halves called the S- and R-enantiomers. With Lexapro, the R-enantiomer (that does not contribute to Celexa's antidepressant activity) has been removed, leaving only the therapeutically active S-enantiomer.

SOURCE: Forest Laboratories

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