AVANIR Pharma (AVNR) Announces Results from Zenvia Phase III STAR Trial

November 10, 2009 9:08 AM EST

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).

Some highlights from the study include:

• 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.

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