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    FDA Approves Nuedexta™ to Treat Episodes of Uncontrollable Laughing or Crying, a Symptom That Can Occur in People with MS

    Posted Monday, November 1, 2010

    News from the National Multiple Sclerosis Society

    October 29, 2010 -
    The first drug specifically developed to treat uncontrollable laughing or crying, also called pseudobulbar affect, or PBA, has been approved by the U.S. Food and Drug Administration. Nuedexta™ (dextromethorphan hydrobromide and quinidine sulfate, formerly called AVP-923, Avanir Pharmaceuticals) is an oral therapy shown in clinical trials to significantly reduce episodes in people with MS, ALS and other disorders.

    Comment: “This FDA approval represents a significant step forward for people who live with the debilitating effects of pseudobulbar affect,” said Dr. Nicholas LaRocca, Vice President of Healthcare Delivery and Policy Research at the National MS Society. “For people who experience unexplained bouts of inappropriate laughing or crying, this new therapy has the potential to substantially help both them and their families.”

    Background: It is currently estimated that approximately 10% of persons with MS experience episodes of uncontrollable laughing and/or crying that are unpredictable and seem to have little or no relationship to actual events or the individual’s actual feelings. This condition, which also affects people with other neurological conditions, is thought to result from lesions – damaged areas – in emotional pathways in the brain. It is important for family members and caregivers to know this, and realize that people who experience these episodes may not always be able to control their expression of emotions. Until now, no medication was approved specifically to treat this condition.

    Avanir Pharmaceuticals has been conducting trials of Nuedexta in its current and earlier formulations for several years as a treatment for pseudobulbar affect in a number of disorders, including MS and ALS. Nuedexta is a patented, orally-administered combination of dextromethorphan and an enzyme inhibitor known as quinidine. Quinidine slows down the breakdown of dextromethorphan in the body, which results in a sustained elevation of dextromethorphan in the brain.

    In 2006, Avanir received a letter from the FDA indicating that the drug was “approvable” and requesting that additional studies be conducted, leading to the phase III study that was recently published. (Annals of Neurology, published online September 13, 2010). Results of that study suggested that the drug significantly reduced the rate of episodes of pseudobulbar affect by about 47-49 percent compared to placebo. Secondary outcomes, including patient diaries and episode-free days, also suggested significant benefit among groups taking Nuedexta.

    Read more on the National MS Society's website


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