Interim results from Avanir Pharmaceuticals' (NASDAQ:AVNR) 450-patient 12-week Phase 4 clinical trial of Nuedexta (dextromethorphan hydrobromide/quinidine sulfate) demonstrate a substantial reduction in symptoms of pseudobulbar effect (PBA) in patients with Alzheimer's disease. PBA is a neurologic condition characterized by sudden and uncontrolled outbursts of laughing and/or crying in patients with neurolgic disease/injury.
At baseline, patients had a mean CNS-LS score of 20.2 and suffered a median of 29 PBA episodes per week. At the end of the study, mean CNS-LS improved to 12.8 and median PBA episodes dropped to 5 per week.
77.8% of patients or caregivers rated themselves/patients as being much/very improved.
79.3% of clinicians rated the patient much/very much improved.
Nuedexta is the only FDA-approved treatment for PBA.