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

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