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Positive Results Reported for Nuedexta (Dextromethorphan/Quinidine) in Patients With Brain Injury or Stroke

Treatment reduces pseudobulbar affect

Nuedexta (Avanir Pharmaceuticals), a combination of dextromethorphan hydrobromide and quinidine sulfate, has been shown to reduce pseudobulbar affect (PBA) in patients with traumatic brain injury (TBI) or stroke in a new phase IV study.

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 open-label PRISM II trial enrolled 367 adult patients (18 years of age or older) with a clinical diagnosis of PBA and a baseline score of 13 or greater on the Center for Neurologic Study–Lability Scale (CNS-LS). A total of 134 patients had dementia/Alzheimer’s disease; 120 patients had TBI; and 113 patients had stroke. Patients with TBI due to a penetrating head injury were excluded from the trial. The patients were treated with Nuedexta twice daily for 12 weeks. The study’s primary endpoint was the change from baseline in PBA symptoms, as measured by the CNS-LS.

In the TBI cohort, the patients had a mean CNS-LS score of 20.5 at baseline and were experiencing a median of 10 PBA episodes per week. At the end of the study, the mean CNS-LS improved to 11.9 (P < 0.001 compared with baseline), and the median number of PBA episodes decreased to one per week, with an overall 78.5% reduction in the episode count compared with baseline (P < 0.001). The most commonly reported adverse event was diarrhea (8.3%).

In the stroke cohort, the patients had a mean CNS-LS score of 20.8 at baseline and were experiencing a median of 10 PBA episodes per week. At the end of the study, the mean CNS-LS improved to 13.1 (P < 0.001 compared with baseline), and the median number of PBA episodes decreased to two per week, with an overall 75.5% reduction in the episode count compared with baseline (P < 0.001). The most common adverse events were diarrhea (4.4%), headache (3.5%), and constipation (2.7%).

Nuedexta is a combination of dextromethorphan hydrobromide (the product’s active ingredient in the central nervous system) and quinidine sulfate (a metabolic inhibitor enabling therapeutic concentrations of dextromethorphan). Dextromethorphan acts on sigma-1 and N-methyl-D-aspartate (NMDA) receptors in the brain, although the mechanism by which Nuedexta exerts its therapeutic effects in patients with PBA is unknown.

Nuedexta was approved for the treatment of PBA in 2010.

Sources: Avanir Pharmaceuticals; June 30, 2015; and Nuedexta Prescribing Information; January 2015.

 

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