The presentation of detailed data, including safety and tolerability data from the open-label extension as well as cardiac safety data from the double-blind phase of the Phase III confirmatory STAR trial evaluating the investigational drug Zenvia™ (dextromethorphan/quinidine) in the treatment of pseudobulbar affect (PBA) was announced in April 15th 2010. The data were presented in two posters at the American Academy of Neurology (AAN) Annual Meeting in Toronto, Canada.

"We are pleased to present these important data at the AAN Annual Meeting and are very satisfied with the safety and tolerability profile that Zenvia demonstrated in both the double-blind and open-label extension phases of the STAR trial," said Randall Kaye, MD, AVANIR's Chief Medical Officer. "The new lower dose formulations of Zenvia have maintained statistically significant and clinically meaningful efficacy while providing an improved safety and tolerability profile relative to the original higher dose formulation. We plan to file our full response with the FDA within the next few weeks and expect an approval decision on the PBA application before the end of this year."

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