May 24, 2006

New Drug May Hold Promise for Stutterers

By Toni Clarke

BOSTON (Reuters) - When Dr. Gerald Maguire was a child, he resolved every New Year's Eve to stop stuttering. The resolution usually lasted less than two hours.

Now Maguire is helping investigate an experimental new drug that he believes could offer hope to the more than 3 million Americans who suffer from the speech disorder.

The drug, pagoclone, is being developed by Indevus Pharmaceuticals Inc. Results of a 132-patient trial released on Wednesday showed that 55 percent of patients taking pagoclone showed a significant improvement in symptoms compared to 36 percent who took a placebo.

Shares of Lexington, Massachusetts-based Indevus rose as much as 10 percent on Wednesday on the news.

Maguire, who is an associate professor of psychiatry at the University of California Irvine School of Medicine, said pagoclone, if approved, would be the first drug specifically designed to treat stuttering.

Today, patients are either not treated, or are treated with drugs that are not approved for the disorder such as the benzodiazepine class of anti-anxiety drugs or antipsychotics such as Zyprexa and Risperdal.

Maguire believes pagoclone may help stutterers without causing the kind of dependence linked to benzodiazepines or the weight gain often associated with the newer antipsychotics.

Pagoclone is designed to heighten activity of the brain chemical GABA, which is thought in turn to block the chemical dopamine. Dopamine, which is responsible for motion and movement, is often too high in people who stutter, Maguire said.

"Stuttering is a neurological disorder that has psychological consequences," he said.

For four years, Maguire did not talk on the phone, as his anxiety overwhelmed his ability to speak. He said the antipsychotic Zyprexa helps.

The disorder, which affects about 1 percent of the adult population, normally begins in childhood. About half of children who develop it grow out of it.

That could be because an area of the brain called the striatum, which acts as the timer and initiator of speech, does not fully develop until later in life. Pagoclone is designed to enhance the functioning of the striatum, Maguire said.

The drug, which was tested in patients for eight weeks, was not associated with any serious complications, Indevus said.

Indevus said it will meet with the U.S. Food and Drug Administration to discuss the findings and plans for further development. By mid-afternoon trading, the company's shares were up 3.8 percent at $4.61 on Nasdaq.

(Additional reporting by Julie Steenhuysen in Chicago)