Otsuka Unit Avanir Reports Phase 3 Data for Agitation in Alzheimer’s

Otsuka’s Subsidiary Avanir Pharmaceuticals Reports Phase 3 Data Evaluating Investigational AVP-786 for the Treatment of Moderate-to-Severe Agitation in Patients with Alzheimer’s Dementia

Otsuka Pharmceutical Co., Ltd. (Otsuka) announces that its U.S. -based, indirect subsidiary Avanir Pharmaceuticals, Inc. (Avanir) reports results from the first study of its phase 3 clinical development program investigating the efficacy, safety and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of moderate-to-severe agitation in patients with Alzheimer’s dementia.

This study, which used the Sequential Parallel Comparison Design (SPCD), demonstrated a significant improvement on the primary endpoint on the Cohen-Mansfield Agitation Inventory for one of the two doses being evaluated; the other dose demonstrated numerical but not significant improvement on the SPCD analysis. Similar improvements were also observed on the key secondary endpoint. The most common adverse events in patients receiving AVP-786 versus placebo (greater than 5% incidence in either of the two doses of AVP-786) were falls, urinary tract infection, headache and diarrhea. Overall mortality during the study was low and none of the deaths were considered related to treatment.

“These initial data from the first phase 3 study are encouraging and we look forward to continuing to evaluate AVP-786 for the treatment of moderate-to-severe agitation in patients with Alzheimer’s dementia as the clinical program progresses,” said Sanjay Dubé, MD, vice president, Research & Development, head of Clinical Development & Scientific Strategy at Avanir. “Currently there is no FDA-approved treatment for agitation in patients with Alzheimer’s dementia. Any advancement in the treatment and management of agitation in patients with Alzheimer’s dementia would help to bridge the treatment gap in these patients. It is important to note that there are two additional phase 3 studies ongoing in the clinical development program, which use a conventional parallel-arm design, rather than the Sequential Parallel Comparison Design used in this first study. We will continue to analyze the full set of data from this first study and plan to communicate more about the results at the time of publication in a peer-reviewed journal,” said Dr. Dubé.

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