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  Avanir says drugs curbs ALS emotional bursts
Posted August 25, 2004 in ALS Research

© Copyright Reuters 2004.
Tue Aug 24, 2004 10:19 AM ET

NEW YORK (Reuters) - Avanir Pharmaceuticals on Tuesday said its experimental drug successfully controlled a symptom of uncontrollable laughter or crying in a late-stage trial of patients with multiple sclerosis.

The San Diego-based company said the Phase III trial involved 150 patients at 22 medical centers, some of whom received its drug Neurodex for 90 days, while others received placebos.

It said patients receiving Neurodex had a statistically significant greater reduction in frequency and severity of episodes than those receiving placebos, the main goal of the trial.

Moreover, they had uniformly better outcomes in secondary goals such as quality of life and pain reduction, the company said in a release.

Neurodex was well tolerated in the trial, with the majority of patients reporting mild or moderate side effects such as dizziness.

Avanir said the condition of uncontrollable laughing or crying, called pseudobulbar affect, also affects patients with other neurological conditions -- such as Lou Gehrig's disease and Alzheimer's disease and those who have had strokes or traumatic brain injury.

The favorable results seen in the study of patients with multiple sclerosis were similar to those seen in a previous trial of patients with Lou Gehrig's disease, formally known as amyotrophic lateral sclerosis (ALS), the company said.

"Through the treatment of pseudobulbar affect, we can eliminate or reduce patients' anxiety about controlling their emotions in social and business settings, thus improving their quality of life," the company said.

Avanir said no prescription medicines are approved for the condition in the United States and that it plans to seek marketing approval of Neurodex based upon favorable results of its two late-stage trials.

Shares of Avanir were up 29 cents, or 15 percent, to $2.18, on the American Stock Exchange.

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