Avanir Reports Positive Results From Phase II Trial Of AVP-923

(RTTNews) - Avanir Pharmaceuticals, Inc. (AVNR) announced positive results from its phase II clinical trial evaluating the safety and efficacy of AVP-923 for the treatment of agitation in patients with Alzheimer's disease. The company said the treatment with AVP-923 was associated with significantly reduced agitation as measured by the primary endpoint, the agitation/aggression domain score of the neuropsychiatric inventory compared to placebo.

The company said the reduction in agitation was observed in both stage 1 and stage 2 of the Sequential Parallel Comparison study design. Improvements were also seen in a majority of the secondary endpoints.

Based on the results, Avanir plans to request a meeting with both the U.S. FDA and the European Medicines Agency with the intention of discussing advancement of its dextromethorphan programs into pivotal studies for the treatment of agitation in patients with Alzheimer's disease.