PRISM II study of Nuedexta (dextromethorphan and quinidine sulphate) reports data for treating pseudobulbar affect- Avanir Pharma

Avanir Pharmaceuticals announced top-line data from the PRISM II study showing that treatment with Nuedexta (dextromethorphan and quinidine sulphate) was associated with a statistically significant reduction in symptoms of pseudobulbar affect (PBA) in patients with traumatic brain injury (TBI) or stroke. 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.

For TBI patients, at the end of the study period, mean CNS-LS improved to 11.9 (P<0.001 compared with baseline) and the median number of PBA episodes decreased to one per week, with an overall 78.5% reduction in episode count compared to baseline (P<0.001). Consistent improvement was observed in other effectiveness endpoints. Additionally, 73.0% of patients or caregivers rated themselves/the patient as being much/very improved on the PGI-C (P<0.001). Also 78.0% of clinicians rated the patient to be much/very much improved on the CGI-C (P<0.001). Finally, adverse events (AE) were reported by 43 patients (35.8%).

For stroke patients, at the end of the study period, mean CNS-LS improved to 13.1 (P<0.001 compared with baseline) and the median number of PBA episodes decreased to two per week with an overall 75.5% reduction in episode count compared to baseline (P<0.001). Consistent improvement was observed in other effectiveness endpoints. 68.0% of patients or caregivers rated themselves/the patient as being much/very improved on the PGI-C (P<0.001). 75.0% of clinicians rated the patient to be much/very much improved on the CGI-C (P<0.001). Data from patients with PBA secondary to TBI were presented at the Annual Symposium of the National Neurotrauma Society.