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Eating Disorders & Phobias

STUDY SHOWS NEURONTIN SIGNIFICANTLY REDUCED SYMPTOMS OF SOCIAL PHOBIA

Morris Plains, NJ, July 12, 1999 -- Results of a new study on patients suffering from social phobia demonstrated a 31 percent decrease in symptoms following treatment with the drug, Neurontin® (gabapentin), compared to a 14 percent reduction for the placebo. Released today in the July/August edition of the Journal of Clinical Psychopharmacology (JCP), the study also showed that Neurontin was generally well tolerated.

The 14-week study involved 69 patients afflicted with social phobia -- also known as social anxiety disorder -- a condition that may affecting as many as 35 million Americans at some point in their lifetime. Research for the study was conducted at Duke University, Durham, North Carolina, and the Dean Foundation for Health, Research and Education, in Middleton, Wisconsin, and was supported by the Parke-Davis Division of Warner-Lambert Company.

"Although some anxiety in social situations is normal, people with social phobia have so much anxiety that they either avoid social situations or endure them with enormous distress," said John H. Greist, M.D., Distinguished Senior Scientist, Madison Institute of Medicine, and Clinical Professor of Psychiatry, University of Wisconsin Medical School, both in Madison, Wisconsin. "Unfortunately, social phobia can affect many aspects of the patient�s life, including family relationships, education, work and sexual relationships."

Typically beginning in childhood or early adolescence, social phobia was among the most common disorders observed in one study in the United States, along with major depressive episode, alcohol dependence, and simple phobia. It is found in women twice as often as in men. While recent epidemiologic studies on social phobia suggest a lifetime prevalence of 13%, only 5% of these patients actually receive medical treatment.

The multi-center study was a randomized, double-blind, placebo controlled, parallel group trial, with patients receiving either a flexible dose of gabapentin (900-3600 mg per day) or placebo for 14 weeks. The Liebowitz Social Anxiety Scale (LSAS) was employed to gauge patient improvement with gabapentin and showed a 28 point decrease on the scale (87.7 vs. 60.3) as compared with a 12 point decrease with placebo (83.5 vs. 71.4). This difference was statistically significant.

LSAS was the first clinician-administered scale to evaluate the wide range of social situations that are difficult for individuals with social phobia, and is used as an outcome measure in most pharmacological trials for social phobia.

"Historically, social phobia has been treated with a number of drugs, most notably selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), and anti-anxiety agents (benzodiazepines)," explained Dr. Greist. "In the study, gabapentin was shown to significantly reduce the symptoms of this disorder."

The most common adverse events during the study in social phobia were infection (29% vs. 23% with placebo); headache (24% vs. 26% with placebo); dizziness (24% vs. 6% with placebo); somnolence (21% vs. 9% with placebo); nervousness (15% vs. 11% with placebo); weakness (15% vs. 9% with placebo); dry mouth (12% vs. 0% with placebo).

Neurontin has not been approved by the FDA for the condition discussed in this study. Neurontin, marketed by Parke-Davis as 100 mg, 300 mg and 400 mg capsules, is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults (>12 years old). The maximum recommended dose of Neurontin for partial seizures is 1,800 mg per day. Neurontin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

The most common adverse events during clinical trials in epilepsy were somnolence (19.3% vs. 8.7% with placebo); dizziness (17.1% vs. 6.9% with placebo); ataxia (12.5% vs. 5.6% with placebo); fatigue (11% vs. 5% with placebo); nystagmus (8.3% vs. 4% with placebo).

Parke-Davis is a division of Warner-Lambert Company, a worldwide company devoted to discovering, developing, manufacturing and marketing quality pharmaceutical, consumer health and confectionery products. It employs more than 43,000 people worldwide.

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