PRISM II: Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg (NUEDEXTA®) for Treatment of Pseudobulbar Affect Secondary to Dementia, Stroke, or Traumatic Brain Injury: Combined Results of a Multicenter Open-Label Study (P2.225)

Objective: To evaluate the effectiveness of dextromethorphan/quinidine (DM/Q) 20/10 mg for treatment of pseudobulbar affect (PBA) in patients with dementia, stroke or traumatic brain injury (TBI).Background: DM/Q is approved to treat PBA regardless of neurologic etiology, based on well-controlled trials in PBA secondary to amyotrophic lateral sclerosis and multiple sclerosis. PRISM II evaluated treatment effectiveness of DM/Q for PBA secondary to dementia, stroke, or TBI.Design/Methods: Open-label, 90-day, US multicenter trial included patients with a diagnosis of PBA secondary to dementia, stroke, or TBI and a Center for Neurologic Study-Lability Scale (CNS-LS) score ≥13 (scale range 7-35). Patients received DM/Q 20/10 mg twice daily (once daily during Week 1). Primary endpoint: change from baseline to Day 90/Endpoint in CNS-LS score (last observation carried forward). Additional endpoints: PBA episodes/week, QOL-VAS, Clinical and Patient/Caregiver’s Global Impression of Change (PGI-C and CGI-C), Patient Health Questionnaire-9 (PHQ-9), MMSE, and adverse events (AEs).Results: 367 enrolled (safety population); 271 (73.8[percnt]) completed; 96 (26.2[percnt]) discontinued early (9.3[percnt] due to AEs). 298 patients were evaluable for effectiveness. Mean [SD] change from baseline to Day 90/Endpoint in CNS-LS score was significant (-7.7 [6.1], P P P P P =0.002). On CGI-C and PGI-C, 72[percnt] and 77[percnt] of patients, respectively, were rated as “much” or “very much” improved. 75[percnt] (197/261) were “somewhat” or “very” satisfied with DM/Q treatment. AEs were reported by 132 (36.0[percnt]) patients and were deemed treatment-related in 55 (15[percnt]). Most common AEs were diarrhea, headache, and urinary tract infection. Serious AEs occurred in 23 (6.3[percnt]) patients; none were considered study-related.Conclusion: The open-label PRISM II study supports DM/Q effectiveness for PBA irrespective of underlying etiology.Study supported by: Avanir Pharmaceuticals, Inc. Disclosure: Dr. Siffert has nothing to disclose. Dr. Hammond has nothing to disclose. Dr. Alexander has nothing to disclose. Dr. Cutler has received personal compensation for activities with Abbott, AstraZeneca, Bristol-Myers Squibb, Forest, GlaxoSmithKline, Lilly, Merck, Novartis, Ortho-McNeil-Janssen, Otsuka, Pamlab, Pfizer, Shire, and Sunovion. Dr. D9Amico has received personal compensation for activities with Avanir Pharmaceuticals, Inc. Dr. Doody has received research support from Accera, Genentech, Merck Serono, and Takeda. Dr. Sauve has received personal compensation for activities with Avanir Pharmaceuticals, Inc. Dr. Zorowitz has received personal compensation for activities with Allergan, Inc. Dr. Davis has received personal compensation for activities with Avanir Pharmaceuticals, Inc. Dr. Shin has received personal compensation for activities with Avanir Pharmaceuticals as an employee. Dr. Ledon has received personal compensation for activities with Avanir Pharmaceuticals, Inc. as an employee. Dr. Yonan has received personal compensation for activities with Avanir Pharmaceuticals, Inc as an employee. Dr. Formella has received personal compensation for activities with Avanir Pharmaceuticals, Inc. as an employee.