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05-27-2006, 12:06 AM
Drug for stutterers shows promise
Indevus says pill reduced incidents for most in 1st trial
By Stephen Heuser, Globe Staff | May 25, 2006
A potential pill to treat stuttering took a step forward yesterday when Indevus Pharmaceuticals Inc. of Lexington said its experimental drug reduced stuttering in a majority of patients in its first clinical trial.
The 132-patient trial is the largest human test ever conducted on a drug for stuttering, according to the company.
Like many diseases that were once treated as primarily emotional disorders, stuttering is now increasingly seen as having deep roots in the biology of the brain, leading sufferers to hope for a medical treatment similar to those for depression. No drugs have been approved specifically to treat stuttering, although severe stutterers are sometimes prescribed psychiatric drugs such as the antipsychotic Zyprexa .
The Indevus drug, called pagoclone , was given to 88 patients in escalating doses, with the rest of the trial subjects receiving a placebo. The patients were then tracked using several widely accepted measures of stuttering.
As the eight-week trial progressed, they were videotaped having conversations and reading aloud. DVDs of those sessions were sent to analysts in Texas who did not know which participants had received the drug.
The analysts graded the patients by counting how many syllables they stuttered on, and how long each blockage lasted. A quick stutter might last no more than a second. A severe sufferer, however, can take a full minute to say a single syllable.
When graded by the analysts, the patients on pagoclone showed less frequent and long-lasting speech blockages than those in the placebo group.
They also showed improvement on a second test, based on patients' own reports of their trouble speaking during the previous week.
On a third rating scale, based on doctors' impressions, the pagoclone patients scored a ``numerically superior rating" to the placebo group, but the finding did not reach statistical significance.
Indevus stock jumped 10 percent yesterday on the news of the clinical trial findings, gaining 44 cents to close at $4.88.
Gerald Maguire , a speech disorder researcher who helped lead the pagoclone test, said the results were promising, and pagoclone appeared to have fewer side effects than the psychiatric drugs currently prescribed for severe stutterers. Pagoclone was originally tested as an anti anxiety medication. Although those tests were unsuccessful, researchers were intrigued by a reduction in some trial subjects' stuttering, and last year Indevus launched a formal test to see whether pagoclone could help stutterers.
Indevus executives plan to meet with federal regulators to discuss what further studies will be necessary before they can apply for market approval.
The company did not estimate when pagoclone might be brought to market. ``We still need to do a good size trial, probably 600 or 1,000 patients, and that's going to take some time to enroll," said company spokesman Brooke Wagner .
Stephen Heuser can be reached at sheuser@globe.com.
© Copyright 2006 The New York Times Company
Indevus says pill reduced incidents for most in 1st trial
By Stephen Heuser, Globe Staff | May 25, 2006
A potential pill to treat stuttering took a step forward yesterday when Indevus Pharmaceuticals Inc. of Lexington said its experimental drug reduced stuttering in a majority of patients in its first clinical trial.
The 132-patient trial is the largest human test ever conducted on a drug for stuttering, according to the company.
Like many diseases that were once treated as primarily emotional disorders, stuttering is now increasingly seen as having deep roots in the biology of the brain, leading sufferers to hope for a medical treatment similar to those for depression. No drugs have been approved specifically to treat stuttering, although severe stutterers are sometimes prescribed psychiatric drugs such as the antipsychotic Zyprexa .
The Indevus drug, called pagoclone , was given to 88 patients in escalating doses, with the rest of the trial subjects receiving a placebo. The patients were then tracked using several widely accepted measures of stuttering.
As the eight-week trial progressed, they were videotaped having conversations and reading aloud. DVDs of those sessions were sent to analysts in Texas who did not know which participants had received the drug.
The analysts graded the patients by counting how many syllables they stuttered on, and how long each blockage lasted. A quick stutter might last no more than a second. A severe sufferer, however, can take a full minute to say a single syllable.
When graded by the analysts, the patients on pagoclone showed less frequent and long-lasting speech blockages than those in the placebo group.
They also showed improvement on a second test, based on patients' own reports of their trouble speaking during the previous week.
On a third rating scale, based on doctors' impressions, the pagoclone patients scored a ``numerically superior rating" to the placebo group, but the finding did not reach statistical significance.
Indevus stock jumped 10 percent yesterday on the news of the clinical trial findings, gaining 44 cents to close at $4.88.
Gerald Maguire , a speech disorder researcher who helped lead the pagoclone test, said the results were promising, and pagoclone appeared to have fewer side effects than the psychiatric drugs currently prescribed for severe stutterers. Pagoclone was originally tested as an anti anxiety medication. Although those tests were unsuccessful, researchers were intrigued by a reduction in some trial subjects' stuttering, and last year Indevus launched a formal test to see whether pagoclone could help stutterers.
Indevus executives plan to meet with federal regulators to discuss what further studies will be necessary before they can apply for market approval.
The company did not estimate when pagoclone might be brought to market. ``We still need to do a good size trial, probably 600 or 1,000 patients, and that's going to take some time to enroll," said company spokesman Brooke Wagner .
Stephen Heuser can be reached at sheuser@globe.com.
© Copyright 2006 The New York Times Company