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Avanir Pharmaceuticals Inc announces presentation of positive early results from PRISM II Study

Wednesday, 16 Jul 2014 09:00am EDT 

Avanir Pharmaceuticals Inc:Says interim data from phase IV PRISM II study showing that treatment with NUEDEXTA substantially reduced symptoms of pseudobulbar affect (PBA) in patients with Alzheimer's disease/dementia.PBA is distressing neurologic condition characterized by sudden and uncontrolled outbursts of laughing and/or crying in patients with neurologic disease and injury.Says standard quality of life measure also showed clear improvement over the 3-month treatment period.Says these initial data showing reduced symptoms of pseudobulbar affect (PBA) in patients with PBA secondary to Alzheimer's and dementia are consistent with the benefits saw in pivotal phase III study.PRISM II assessed the safety and efficacy of NUEDEXTA in treating PBA in patients with Alzheimer's disease/dementia, stroke and TBI.Says at baseline patients had a mean CNS-LS score of 20.2 and were suffering from a median of 29 PBA episodes per week.Says at end of study period, mean CNS-LS improved to 12.8 ( P <0.001 compared with baseline) and the median number of PBA episodes decreased to 5 per week.Says at the end of the treatment period, consistent improvement was observed in other effectiveness measures.Says mean QOL scores improved from 6.1 at baseline to 2.8 at endpoint (P<0.001).Says 77.8 pct of patients or caregivers rated themselves/the patient as being much/very improved on the PGI-C. 

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0.04 +0.66%
26 Aug 2014