New phase IV results show significant improvement with Nuedexta (dextromethorphan and quinidine sulphate) in pseudobulbar affect- Avanir Pharma

Avanir Pharmaceuticals announced new findings from the dementia/Alzheimer's disease cohort of the PRISM II study, a Phase IV study evaluating the safety and effectiveness of Nuedexta (dextromethorphan and quinidine sulphate) in treating pseudobulbar affect (PBA) in patients with dementia/Alzheimer's disease, stroke and traumatic brain injury (TBI). New post-hoc analysis analyzed the differential effects on PBA of Nuedexta based on concomitant antidepressant usage in patients with PBA secondary to dementia/Alzheimer's disease. At baseline, 76 patients (57.0%) were receiving concomitant antidepressants. Improvements in mean Center for Neurologic Study-Lability Scale (CNS-LS) score at final visit vs. baseline and PBA episode count were significant (P<0.001 for all) irrespective of antidepressant use.

Similar percentages of antidepressant users vs. non-users were rated "much"/"very much" improved on Patient Global Impression of Change (PGI-C;74.1% vs. 79.5%) and Clinician Global Impression of Change (CGI-C;74.1% vs. 81.8%). Adverse events (AEs) occurred in 28 (36.8%) concomitant antidepressant users vs. 21 (36.2%) non-users. The most common AEs were headache (7.9% vs. 6.9%), urinary tract infection (2.6% vs. 6.9%), and diarrhoea (2.6% vs 5.2%). The data were presented at the 2015 Alzheimer's Association International Conference.