Avanir: Positive Top-line Results From Stroke, TBI Cohorts Of PRISM II Study

(RTTNews) - Avanir Pharmaceuticals Inc (AVNR) on Tuesday announced top-line data from the PRISM II study showing that treatment with NUEDEXTA was associated with a statistically significant reduction in symptoms of pseudobulbar affect ("PBA") in patients with traumatic brain injury ("TBI") or stroke.

PBA is a distressing condition characterized by sudden and uncontrollable outbursts of laughing and/or crying resulting from certain neurologic diseases or brain injury.

The PRISM II study 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.

The study enrolled 367 patients who were NUEDEXTA twice daily for 12 weeks. Eligible patients were age =18 years with a clinical diagnosis of PBA and baseline score =13 on the CNS-LS. .

The primary endpoint of the study was change from baseline in PBA symptoms as measured by the CNS-LS, an instrument originally validated as a measure of PBA episode frequency and severity in patients with ALS and MS.

Determination of effectiveness was based on a comparison of CNS-LS change in PRISM II with that seen for NUEDEXTA and placebo in a previous pivotal phase III study.