Avanir announced data from the phase 3 clinical program that evaluated AVP-786 (deudextromethorphan hydrobromide/quinidine sulfate) for the treatment of moderate-to-severe agitation in patients with Alzheimer dementia.
AVP-786 combines deudextromethorphan hydrobromide and quinidine sulfate, a CYP2D6 inhibitor. Deuteration was shown to significantly lower susceptibility to CYP2D6 metabolism, resulting in higher bioavailability.
The 12-week, multicenter, randomized, double-blind, placebo-controlled study (15-AVP-786-301; N=410) utilized the Sequential Parallel Comparison Design (SPCD) and included patients aged 50 to 90 years old with moderate-to-severe agitation and probable Alzheimer dementia. Patients were randomized to 1 of 2 doses of the study drug or placebo in stage 1 (6 weeks); those randomized to the study drug continued their assigned drug in stage 2 (6 weeks) whereas patients who received placebo in stage 1 were re-randomized to either drug dose or placebo; only placebo non-responders were used in the SPCD analysis.
The data showed a significant improvement on the Cohen-Mansfield Agitation Inventory (primary endpoint) for 1 of the 2 doses being evaluated. The other dose showed numerical improvement on the SPCD analysis but was not significant.
Falls, urinary tract infection, headache, and diarrhea were the most common adverse events associated with AVP-786 vs placebo. Deaths that occurred during the study were not considered treatment-related.
“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,” stated Sanjay Dubé, MD, Vice President, Research & Development, Head of Clinical Development & Scientific Strategy, Avanir Pharmaceuticals, Inc.
There are two additional ongoing phase 3 studies in the clinical development program (15-AVP-786-302 and 17-AVP-786-305) that employ the conventional parallel-arm design instead of the SPCD used in the first study.
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