Encouraging Ph III data for AVP-786 in agitation in patients with Alzheimer's dementia

25 March 2019

In what seems to be rare these days, USA-based Avanir Pharmaceuticals has presented positive new late-stage data for its AVP-786 in the Alzheimer’s setting.

Avanir, a subsidiary of Japan’s Otsuka (TYO: 4578), today revealed he results from the first study of the company's Phase III 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.

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