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

ly meaningful impact that treatment with NUEDEXTA may have."

PRISM II assessed the safety and efficacy of NUEDEXTA in treating PBA in patients with Alzheimer's disease/dementia, stroke and TBI. 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). The study endpoints included a PBA symptom rating (Center for Neurologic Study-Lability Scale; CNS-LS; 7=no symptoms – 35=maximum symptoms), number of weekly PBA episodes, Mini-Mental State Examination (MMSE), quality of life (QOL; 0=no impairment-10=maximum impairment) improvements, and Clinician and Patient Global Impression of Change (CGI-C; PGI-C).

  • 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 (P<0.001 compared with baseline) 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 (P<0.001)
    • 77.8% of patients or caregivers rated themselves/the patient as being much/very improved on the PGI-C
    • 79.3% of clinicians rated the patient to be much/very much improved on the CGI-C
  • MMSE mean score improved by 0.4 points at end of study from a baseline of 19.0
  • Adverse Events (AE) 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%). Eleven patients had serious AEs (only one deemed treatment-related).  Thirteen patients discontinued for AEs. This AE profile was genera
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SOURCE Avanir Pharmaceuticals, Inc.
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