Nuedexta provides meaningful reduction of PBA episodes for stroke or traumatic brain injury

USA-based CNS specialist Avanir Pharmaceutical released top-line data from the PRISM II study showing that treatment with Nuedexta (dextromethorphan hydrobromide/ quinidine sulfate) was associated with a statistically significant reduction in symptoms of pseudobulbar affect (PBA) in patients with traumatic brain injury (TBI) or stroke.

Avanir, which was acquired last year by Japan’s Otsuka (TYO: 4768) for $3.5 billion (The Pharma Letter December 2, 2014), notes that PBA is a distressing condition characterized by sudden and uncontrollable outbursts of laughing and/or crying resulting from certain neurologic diseases or brain injury.

PRISM II is a Phase IV study evaluating the safety and effectiveness of Nuedexta in treating PBA in patients with dementia/Alzheimer's disease, stroke and TBI. Data from patients with PBA secondary to TBI were presented on June 29 at the 33rd Annual Symposium of the National Neurotrauma Society in Santa Fe, New Mexico. Data from patients with PBA secondary to dementia/Alzheimer's disease were presented at last year's American Neurological Association Meeting, and full results from the stroke cohort will be presented at a future date.