The STAR (safety, tolerability and efficacy results of AVP-923 in pseudobulbar affect or PBA) trial will compare active treatment with Zenvia 30/10mg (dextromethorphan/quinidine or DM/Q) and Zenvia 20/10mg (DM/Q) to placebo during a three-month, double-blinded phase, followed by a three-month, open-label extension study. The STAR trial is being conducted under a special protocol assessment from the FDA.
Randall Kaye, chief medical officer of Avanir, said: “We are pleased to initiate the STAR trial on schedule, which keeps us on track to complete patient enrollment within the next 15 to 18 months and report top-line data in the second half of calendar 2009. We believe this single confirmatory Phase III STAR trial, in addition to certain preclinical studies already underway, will be sufficient to provide a complete response to the FDA’s October 2006 approvable letter for Zenvia in the treatment of PBA.”