Interim data on Phase IV trial of Nuedexta in PBA - Avanir Pharma

Avanir Pharmaceuticals has announced interim data from the Phase IV PRISM II study showing that treatment with Nuedexta (dextromethorphan and quinidine sulphate) substantially reduced symptoms of PseudoBulbar Affect (PBA) in patients with Alzheimer's disease/dementia. While the Alzheimer's disease/dementia cohort is now fully enrolled at 134 patients, at the time of interim analysis 96 patients had evaluable safety data and 68 had effectiveness data (at least 30 treatment days). At baseline patients had a mean CNS-LS score of 20.2 and were suffering from a median of 29 PBA episodes per week. At the end of the study period, mean CNS-LS improved to 12.8 and the median number of PBA episodes decreased to 5 per week. At the end of the treatment period, consistent improvement was observed in other effectiveness measures: mean QOL scores improved from 6.1 at baseline to 2.8 at endpoint.

In addition, 77.8% of patients or caregivers rated themselves/the patient as being much/very improved on the PGI-C. Some 79.3% of clinicians rated the patient to be much/very much improved on the CGI-C. Finally MMSE mean score improved by 0.4 points at end of study from a baseline of 19.0. Adverse Events were reported by a total of 35 (36.5%) patients (6.3% treatment-related), most commonly headache (9.4%), urinary tract infection (5.2%), and diarrhea (4.2%). A standard quality of life measure also showed clear improvement over the 3-month treatment period. The data were presented at the Alzheimer's Association International Conference.