Phase 3 study of agitation drug fails to achieve primary efficacy endpoint

Otsuka has announced that a phase 3 clinical trial of AVP-786, a combination therapy to treat agitation associated with dementia due to Alzheimer’s disease, failed to achieve its primary endpoints.

According to a company release, the therapy failed to achieve a statistically significant difference in mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between AVP-786 — a combination of deudextromethorphan hydrobromide and quinidine sulfate, a CYP2D6 inhibitor — and placebo.

Additionally, one treatment-emergent adverse event, a fall, had an incidence rate of more than 5% in patients treated with AVP-786. There were 16 falls reported in the AVP-786 high dose cohort, 18 in the AVP-786 low dose group and six among those given placebo. There were also four deaths reported in the trial, one in the AVP-786 low dose group and three in the placebo group.

Otsuka stated it intends to submit full trial results, when they become available, for scientific publication at an unknown future date.

“While the result of this trial is disappointing, we plan to analyze the full data set to determine the future potential of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease,” John Kraus, MD, PhD, executive VP and chief medical officer at Otsuka, said in the release. “We are deeply grateful to all of the study participants, their caregivers and the investigators who took part in this trial and contributed to this research.”