AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ (dextromethorphan/quinidine) compared to placebo in the treatment of pseudobulbar affect (PBA) in patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). Over the course of the 12-week study, Zenvia 30/10 mg and 20/10 mg met the primary efficacy endpoint by reducing PBA episode rates by an incremental 47.2% and 47.8% respectively, beyond placebo (p<0.0001). These results were presented today during a late-breaker poster session at the 134th Annual Meeting of the American Neurological Association in Baltimore, MD (Poster Number: WIP-24).
EFFICACY HIGHLIGHTS
- Both the Zenvia 30/10 mg and 20/10 mg groups met the primary efficacy endpoint by demonstrating a significant reduction in daily PBA episode rates relative to the placebo group
- The proportion of patients with complete remission of PBA episodes was significantly greater in both Zenvia treatment groups versus placebo
- The percent of days that were episode-free was significantly higher in the Zenvia groups versus placebo
- Zenvia 30/10 mg demonstrated statistical superiority in time to onset of clinically meaningful effect
- Both Zenvia groups demonstrated a greater proportion of patients versus placebo that achieved response thresholds of 50%, 75% and 90% improvement
- Mean reduction from baseline in CNS-LS score was significantly greater for both Zenvia treatment groups than in the placebo group
- Zenvia 30/10 mg demonstrated significantly greater mean improvement in SF-36 Mental Health Summary scores compared to placebo
- Zenvia 30/10 mg demonstrated significantly greater mean improvement in Beck Depression Inventory scores compared to placebo
In an additional analysis of the primary endpoint pre-specified in the protocol, the percentage of patients that achieved and maintained complete episode remission during the last 14 days of the study was 76% in the Zenvia 30/10 mg group, 80% in the 20/10 mg group and 61% in the placebo group>
p<0.0001 for overall treatment effect throughout the entire study. aITT = intent-to-treat population, refers to all patients randomized.