ALISO VIEJO, Calif.
June 30, 2014
Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) today announced that data related to pseudobulbar affect (PBA), a neurological condition characterized by disruptive, uncontrollable episodes of laughing or crying, and NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate), the only FDA-approved product for the treatment of PBA, will be presented at the Alzheimer's Association International Conference (AAIC), being held at the Bela Center in
July 12-17, 2014
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 CohortPoster Number: 45758Presentation Date/Time:
Wednesday, July 16, 2014
2:15 p.m. CET
Title: Prevalence and Correlates of Pseudobulbar Affect (PBA) Symptoms in Nursing Home ResidentsPoster Number: 45786Presentation Date/Time:
Wednesday, July 16, 2014
2:15 p.m. CET
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 such as 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
450 patients at approximately 100 study centers. The Alzheimer's disease/dementia cohort is fully enrolled at 134 patients. 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), a PBA rating instrument. Patients with TBI due to a penetrating head injury are excluded. Patients are treated with DMQ 20/10 mg twice daily. The primary endpoint is change from baseline in CNS-LS score. 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 PBA episodes (laughing and/or crying); Mini-Mental State Examination; quality of life; Clinician and Patient Global Impression (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.
About the Nursing Home Study
This study evaluated the prevalence and correlates of PBA symptoms in a sample of US nursing home residents. 810 residents across 9 nursing homes i
were screened and their charts reviewed. The analysis population was the subset of nursing home residents having a neurological diagnosis. Clinical assessments included the CNS-LS and a PBA diagnostic checklist.
PBA is a neurologic condition characterized by uncontrollable, disruptive laughing and/or crying outbursts that are often contrary or exaggerated to the patient's inner mood state. As a result, many of those afflicted with PBA show significant impairment on standard measures of health status, and impairments in occupational and social function, often leading to social isolation. PBA occurs secondary to a variety of neurologic conditions such as traumatic brain injury (TBI), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, stroke and Alzheimer's disease. When these disorders damage areas of the brain that regulate normal emotional expression, they can lead to uncontrollable, disruptive episodes of crying or laughing. For more information about PBA, please visit
The CNS-LS has been validated in ALS and MS patients.