Avanir Pharmaceuticals has announced data on pseudobulbar affect, a neurological condition characterized by disruptive, uncontrollable episodes of laughing or crying, and NUEDEXTA®, the only FDA-approved product for the treatment of PBA. Results will be presented at the Alzheimer’s Association International Conference in Copenhagen, Denmark, which runs July 12 through 17.
The study looked at the effectiveness of NUEDEXTA capsules over 12 weeks for patients with PBA due to neurological conditions including dementia, stroke or traumatic brain injury.
The poster presentation is titled “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.” The primary endpoint is change from baseline in CNS-LS score.
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.