Avanir PBA Drug Meets Phase III Goals

Avanir‘s investigational drug Zenvia met its primary efficacy endpoint in the treatment of pseudobulbar affect (PBA) in a confirmatory Phase III trial. Both Zenvia 30/10 mg and 20/10 mg provided a statistically significant reduction in episode rates over the course of the study when compared to placebo (p<0.0001). In an additional analysis of the primary endpoint, at week 12 (end of study), patients in the 30/10 mg group reported a statistically significant mean reduction of 88% from baseline in PBA episode rates (p=0.01). Zenvia was generally safe and well tolerated in the study.

PBA, also known as emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays. PBA is estimated to impact approximately 2 million people in the U.S. with underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson’s disease, dementias including Alzheimer’s disease, stroke, and traumatic brain injury.

“The trial data indicate that the new low-dose Zenvia formulations offer an improved safety and tolerability profile while continuing to deliver statistically significant and clinically meaningful efficacy in the treatment of PBA,” said Keith Katkin, Avanir’s president and chief executive officer. “We are very encouraged by the top-line results and we believe that the data should be sufficient to address the issues outlined in the FDA approvable letter. We hope to have a full presentation of the trial results at a scientific meeting later this year and plan to submit our complete response to the FDA in the first half of 2010.”

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