Avanir Pharmaceuticals, Inc announced 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. 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 twelve (end of study), patients in the Zenvia 30/10 mg group reported a statistically significant mean reduction of 88 per cent from baseline in PBA episode rates (p=0.01). Also in this study, Zenvia was generally safe and well tolerated.
"Frequent, unpredictable and often intense emotional outbursts may take a devastating toll on patients with PBA and their loved ones. The results of the STAR trial indicate that the new low dose formulation of Zenvia can substantially reduce the number of PBA episodes that these patients experience," said Jeffrey Cummings, MD, Augustus Rose professor of Neurology at the David Geffen School of Medicine at UCLA and Steering Committee Chairman for the STAR trial. "With no FDA approved treatments currently available, there is a real unmet medical need for the estimated 2 million patients in the US living with the burden of PBA."
"The STAR 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 CEO. "We are very encouraged by the top-line results and we believe that the STAR data should be sufficient to address the issues outlined in the FDA approvable letter. We hope to have a full presentation of the STAR 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."
Zenvia (dextromethorphan/quinidine) is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on acquiring, developing, and commercializing novel therapeutic products for the treatment of central nervous system disorders.