Avanir has reported that the investigational drug Zenvia (dextromethorphan/quinidine) has met its primary efficacy endpoint in the confirmatory phase III STAR trial, for the treatment of pseudobulbar affect (PBA).
Zenvia is a combination of two compounds, dextromethorphan and the enzyme inhibitor – quinidine, which serves to increase the bioavailability of dextromethorphan.
The company said that in the study, Zenvia was generally safe and well tolerated. The STAR trial demonstrated that 90.9%, 82.2% and 86.2% of patients completed the 12-week double blind phase of the study in the Zenvia 30/10mg, Zenvia20/10mg and placebo groups, respectively.
Reportedly, both Zenvia 30/10mg and 20/10mg has provided a significant reduction in episode rates over the course of the study, when compared to placebo.
As per the analysis of the primary endpoint at week twelve, patients in the Zenvia 30/10mg group reported a significant mean reduction of 88% from baseline in PBA episode rates.
Keith Katkin, president and CEO of Avanir, said: 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.
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, she said.