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Avanir Pharmaceuticals Announces Presentation of Positive Early Results from PRISM II Study
Date:7/16/2014

lly consistent with that observed in other trials of NUEDEXTA. 

About PRISM II
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg dextromethorphan (DM) and 10 mg quinidine (Q) for treatment of PBA in patients with prevalent neurological conditions including Alzheimer's disease/dementia, stroke and traumatic brain injury over a 12 week period.

PRISM II is a nationwide, open-label, multicenter, 12-week study enrolling up to approximately 450 patients at approximately 100 study centers. Eligible patients are aged >18 years with a clinical diagnosis of PBA and baseline score >13 on the Center for Neurologic Study-Lability Scale (CNS-LS). Patients with TBI due to a penetrating head injury are excluded. Patients are treated with NUEDEXTA mg twice daily. The primary endpoint is change from baseline in scores measured by the CNS-LS, a PBA rating instrument originally validated in patients with PBA secondary to ALS and MS. Determination of effectiveness is based on a comparison of CNS-LS change in PRISM II with results of previous phase III studies. Additional outcomes measures include: number of weekly PBA episodes (laughing and/or crying); Mini-Mental State Examination; quality of life; Clinician and Patient Global Impression of Change (CGIC; PGIC); patients' satisfaction with treatment; Patient Health Questionnaire (PHQ-9) (to evaluate mood symptoms), and the Neurobehavioral Functioning Inventory for TBI patients. Safety measures include monitoring of adverse events, concomitant medication usage, and vital signs.

Poster Presentation Details:
Title: PRISM II: An Open-Label Study to Assess the Safety, Tolerability, and Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg (NUEDEXTA) in Pseudobulbar Affect  (PBA) Secondary to Dementia, Stroke, or Traumatic Brain Injury (TBI): Early Results of the Alzheimer's Disease/Dementia Cohort'/>"/>

SOURCE Avanir Pharmaceuticals, Inc.
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