Avanir Pharmaceuticals Announces JAMA Publication of Phase II Study Results Showing AVP-923 Significantly Reduced Agitation in Patients with Alzheimer's Disease

Avanir Pharmaceuticals, Inc. today announced that results from a phase II study evaluating the efficacy and safety of AVP-923 for the treatment of agitation in patients with Alzheimer's disease were published today in the Journal of the American Medical Association (JAMA). The study showed that patients with moderate to severe agitation secondary to Alzheimer's disease who were treated with AVP-923 (a combination of dextromethorphan and quinidine) had a clinically meaningful and statistically significant improvement measured by the agitation/aggression domain of the Neuropsychiatric Inventory (NPI), compared with patients treated with placebo (p<0.001; primary endpoint). The treatment effect with AVP-923 was evident by week one (p=0.04) and remained significant at the end of the 10-week study. Additionally, statistically significant clinical effects were observed with AVP-923 across the majority of secondary endpoints, including the NPI total score, clinical global impression of change-agitation, patient global impression of change and measures of caregiver burden. AVP-923 was shown to be generally well tolerated in this elderly population that also received multiple concomitant medications during the study period. Treatment-emergent adverse events were consistent with the known safety profile of AVP-923. The most common adverse events were falls, diarrhea, and