Aliso Viejo-based AVANIR Pharmaceuticals Inc. announced Tuesday that the investigational drug Zenvia (dextromethorphan/quinidine) met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in the confirmatory Phase III STAR trial.
“PBA is a condition characterized by episodes of uncontrollable laughing and/or crying that may be inappropriate, unrelated to the situation at hand, or not expressing the person's mood,” says the STAR trial Web site, “The condition is known by other terms, including emotional lability, emotional incontinence, and pathological laughing and crying.
“PBA is associated with neurologic disorders that may include, but are not limited to multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), dementias including Alzheimer's disease, Parkinson's disease, stroke, and traumatic brain injury.”
Both Zenvia 30/10 mg and 20/10 mg exhibited a statistically significant reduction in episode rates over the course of the study when compared to placebo.
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