Avanir Pharmaceuticals, Inc. (AVNR) said Tuesday that the European Commission has approved Nuedexta in the European Union for the treatment of pseudobulbar affect, irrespective of underlying neurologic disease or injury.
Pseudobulbar affect is a neurologic condition characterized by outbursts of uncontrollable crying or laughing that are often contrary or exaggerated to the patient's inner mood state. As a result, many of those afflicted with pseudobulbar affect show significant impairment on standard measures of health status, and disruption in occupational and social function, often leading to social isolation. pseudobulbar affect occurs secondary to a variety of neurologic conditions such as traumatic brain injury, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, stroke and Alzheimer's disease. Nuedexta is approved in the U.S. for the treatment of pseudobulbar affect with a 20/10 mg dose strength. It is now approved in all 27 member states of the European Union, plus Iceland and Norway, for the treatment of PBA with a 20/10 mg and 30/10 mg dose strength.
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