Public Release:  New treatment helps control involuntary crying and laughing -- common in MS, ALS patients

Embargoed for release until 3 p.m. ET, Tuesday, April 13, 2010

American Academy of Neurology

TORONTO - Pseudobulbar affect (PBA) is a neurologic condition of involuntary, sudden and frequent episodes of laughing or crying and is quite common in patients with underlying neurologic diseases or injuries, especially those with multiple sclerosis (MS) and amyotrophic lateral sclerosis (ALS). Now, a new investigational treatment may help stop these involuntary outbursts. The research will be presented as part of the late-breaking science program at the American Academy of Neurology's 62nd Annual Meeting in Toronto, April 10 - 17, 2010.

"These outbursts of crying and laughter at inappropriate times can have a severe impact on patient and caregiver well-being, social functioning and quality of life," said study author Erik P. Pioro, MD, PhD, FRCPC, Director of the Section for ALS and Related Disorders at the Cleveland Clinic in Cleveland, Ohio, and a member of the American Academy of Neurology.

The study in patients diagnosed with PBA tested the effectiveness of a combination of two medications, dextromethorphan and low dose quinidine. The combination of the drugs is known as DMQ. After completing the blinded, placebo controlled phase of the study, participants could take part in a subsequent open label study where all of the participants would receive the DMQ drug combination for an additional 12 weeks. Of the 283 people completing the first phase, 253, or 89 percent, chose to take part in this subsequent open label study.

Participants were given daily doses of DMQ and were regularly given a test that measures the frequency and severity of their PBA. The study found that the average test score was significantly improved by 2.7 points from the start to the end of the open label study. Patients who were taking a placebo in the previous clinical trial and switched to DMQ demonstrated the most improvement.

"Our findings represent the first long-term results showing DMQ is effective in helping to control this debilitating condition afflicting patients with neurologic diseases or injuries," said Pioro. "Currently, there are no FDA approved treatments for PBA, which is problematic because currently used off-label treatments are often ineffective or may have unacceptable side-effects."

Pioro says these findings, along with additional clinical data, will serve as the basis for an application for FDA approval of DMQ as the first treatment for pseudobulbar affect.

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The study was supported by Avanir Pharmaceuticals, Inc.

The American Academy of Neurology's Annual Meeting is the world's largest gathering of neurologists with more than 2,300 scientific research presentations on brain disorders.

The American Academy of Neurology, an association of more than 22,000 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as Alzheimer's disease, Parkinson's disease, ALS (Lou Gehrig's disease), multiple sclerosis, stroke and migraine. For more information about the American Academy of Neurology, visit http://www.aan.com.

Editor's Note:

Dr. Pioro will be available for media questions during a press conference at 2:00 p.m. ET, on Tuesday, April 13, 2010, in Room 803B of the Metro Toronto Convention Centre in Toronto. Please contact Rachel Seroka, rseroka@aan.com, to receive conference call information for those reporters covering the press conference off-site.

Dr. Pioro is also available for advance interviews as well. Please contact Rachel Seroka, rseroka@aan.com, to schedule an advance interview.

Dr. Pioro is scheduled to present his late-breaking abstract, P02.296, at 3:00 p.m., ET, on Tuesday, April 13, 2010, in Room 808 of the Metro Toronto Convention Centre in Toronto.

To view non-late-breaking abstracts to be presented at the 2010 AAN Annual Meeting, visit http://www.aan.com/go/am10/science. Late-breaking abstracts will not be posted online in advance of the meeting and are embargoed until the date and time of presentation at the AAN Annual Meeting in Toronto or unless otherwise noted by the Academy's Media and Public Relations Department.

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