European Medicines Agency Recommends Approval of NUEDEXTA in Europe

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended “NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) be approved for the treatment of pseudobulbar affect (PBA), irrespective of neurologic cause.” Although this is encouraging news to the European community, the European Commission (EC) will have the final say over whether NUEDEXTA will be approved for use (although the EC usually takes the recommendation of CHMP). NUEDEXTA was approved by the U.S. Food and Drug Administration in October 2010 for PBA, which is a neurologic condition characterized by frequent outbursts of involuntary crying or laughing. PBA occurs in ALS, multiple sclerosis, traumatic brain injury as well as in Alzheimer’s disease and Parkinson’s disease.

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