Avanir Completes Enrollment In Zenvia Study

Avanir has announced that the open label extension of the confirmatory phase III STAR trial is now fully enrolled.

The primary objective of the study is to assess the long-term safety of Zenvia (dextromethorphan/quinidine) in patients with pseudobulbar affect, resulting from an underlying neurological disorder.

The company said that 282 of 326 patients (86.5%) completed the 12-week double-blind phase of the study, and were eligible to enroll in the open label extension phase. A total of 253 (89.7%) of eligible patients are elected to enroll in the 12-week open label safety extension.

Randall Kaye, CMO of Avanir, said: Completion of the blinded phase and full enrollment of the open label phase of the Star trial are important milestones for Avanir. We look forward to unblinding the top-line data in August 2009 and expect to have data from the open label extension available by the end of the year. With the complete data set from the Star trial in hand, we plan to submit our full response to the approvable letter in the first half of 2010.