Avanir May Gain Second Regulatory Backing for Nuedexta

by Andrew Berens, MD, Senior Healthcare Analyst and Grace Guo, Bloomberg Industries

Avanir’s Nuedexta may receive a decision from the Committee for Medicinal Products for Human Use (CHMP) this week as a treatment for pseudobulbar affect (PBA). Approval in the EU would be the second regulatory nod for the drug.

PBA is also called emotional lability (incontinence) and is characterized by involuntary, sudden, and frequent episodes of laughing or crying. It occurs in patients with certain underlying neurologic diseases or injuries like multiple sclerosis (MS), Lou Gehrig’s disease (ALS ), Parkinson’s disease or Alzheimer’s.


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