Avanir Pharmaceuticals Announces Positive Phase II Trial Results For AVP-923 In Treatment Of Agitation In Patients With Alzheimer's Disease

Avanir Pharmaceuticals, Inc.

today 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. 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 (NPI) compared to placebo (p=0.00008). The reduction in agitation was observed in both stage 1 (p=0.0002) and stage 2 (p=0.021) of the Sequential Parallel Comparison study design. In addition, improvements were also seen in a majority of the secondary endpoints including the NPI total score (p=0.014), clinical global impression of change-agitation (p=0.0003), patient global impression of change (p=0.001) and measures of caregiver burden (p≤0.05). "This is an exciting advancement in Alzheimer's disease research," said Jeffrey Cummings, MD, director of the Cleveland Clinic Lou Ruvo Center for Brain Health and chair of the study steering committee. "Dementia-related neuropsychiatric symptoms such as agitation are extremely distressing to patients and their families." "A potential new treatment option that could alleviate agitation or aggression as a result of Alzheimer's disease would have a significant impact on the daily life of these patients and of their caregivers," added Constantine Lyketsos, MD, director of the Johns Hopkins Memory and Alzheimer's Treatment Center and also a member of the study steering committee. "With no FDA approved drugs for the treatment of agitation in Alzheimer's disease, we believe these results represent a breakthrough for patients," said Joao Siffert, MD, chief medical officer at Avanir. "We are extremely excited with the prospect of bringing a potential treatment that can provide clinically meaningful relief to these patients and reduce caregiver burden. These study results represent the second neuropsychiatric disorder where AVP-923 has shown benefit and lends support for further advancement of our research programs into related disorders." Data from this phase II study will be presented at the American Neurological Association's (ANA) 2014 Annual Meeting in Baltimore, MD, October, 12-14, 2014. Based on these results Avanir plans to request a meeting with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) with the intention of discussing advancement of its dextromethorphan programs into pivotal studies for the treatment of agitation in patients with Alzheimer's disease. AVP-923 was found to be generally well-tolerated in this phase II study. The most common adverse reactions were falls, diarrhea, and urinary tract infection occurring in less than 10 percent of patients. There was a low patient discontinuation rate and there were no serious adverse events that were deemed treatment related by the investigators. AVP-923 is known to have certain risks (see 'About AVP-923' section below).