Avanir Pharmaceuticals unveils Star trial results for Zenvia in the treatment of PBA

AVANIR Pharmaceuticals, Inc.Nov 11 2009

AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced efficacy, safety and tolerability results from the 12-week open-label extension phase of the confirmatory Phase III STAR trial evaluating the investigational drug Zenvia™ (dextromethorphan/quinidine) in the treatment of patients with pseudobulbar affect (PBA).

STUDY HIGHLIGHTS:

• Patients maintained on Zenvia 30/10 mg demonstrated statistically significant incremental improvement in their CNS-LS scores over the additional 12-week treatment period of the open-label study (p<0.0001)
• Patients that titrated from Zenvia 20/10 mg to Zenvia 30/10 mg demonstrated statistically significant incremental improvement in their CNS-LS scores (p<0.0001)
• Patients originally on placebo that initiated Zenvia 30/10 mg demonstrated statistically significant improvement in their CNS- LS scores (p<0.0001)
• Zenvia 30/10 mg was generally safe and well tolerated with 92.9% of patients completing the 12-week treatment period of the open-label study
• Reported rates of adverse events (AEs) were low overall, mild to moderate in nature and consistent with the reported AEs in the double-blind phase
• The overall mortality rate observed in patients with amyotrophic lateral sclerosis, or ALS, (a terminal condition) was consistent with historic norms

“These long term STAR data suggest that the new low dose formulation of Zenvia provides sustained efficacy by reducing the frequency and severity of PBA episodes over a 6 month treatment period,” said Randall Kaye, MD, AVANIR's Chief Medical Officer. “This is the first time the efficacy of Zenvia has been studied beyond 12 weeks and we are very pleased to see the durability of response over a 24-week period. Furthermore, the new low dose Zenvia formulation demonstrated a favorable long term safety and tolerability profile with a low overall rate of reported adverse events.”

"These open-label data from the extension phase of the STAR trial are the final data elements necessary to submit a complete response to the FDA approvable letter," said Keith Katkin, AVANIR's President and CEO. “Our team is working to file a complete response early in the second calendar quarter of 2010, with an FDA approval decision expected approximately six months later. If approved by the FDA, we hope to make Zenvia available as quickly as possible to the significant number of patients in the U.S. currently suffering from the debilitating episodes of PBA."