Otsuka/Avanir's AVP-786 failure adds another flop for Alzheimer's

In yet another setback in the search for Alzheimer’s therapies, Otsuka Pharmaceutical (TYO: 4768) today announced that its USA-based, indirect subsidiary Avanir Pharmaceuticals has reported disappointing results from the second study of its 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.

The trial did not meet its primary endpoint and key secondary endpoints. Patients treated with AVP-786 did not experience a statistically-significant improvement in agitation compared to patients treated with placebo, as measured by the CohenMansfield Agitation Inventory (CMAI, a 29-item scale to measure agitation), the trial’s primary endpoint.

This was a 12-week, multicenter, randomized, double-blind, and placebo-controlled study. The most common adverse events in patients receiving AVP-786 versus those receiving placebo were falls, urinary tract infection, and somnolence (greater than 5% incidence). No deaths were considered related to treatment.