Otsuka Pharmaceutical has disclosed topline data from a Phase III clinical trial of AVP-786, a drug intended for the treatment of agitation linked to dementia in Alzheimer’s disease patients.
AVP-786 is a formulation comprising deudextromethorphan hydrobromide (d6-DM) and quinidine sulfate (Q).
The multicentre, randomised, double-blind, placebo-controlled, parallel-design trial is designed to assess the efficacy, safety, and tolerability of the medication compared to a placebo.
It involved nearly 550 subjects across 90 centres globally who were given the oral treatment twice a day for 12 weeks.
According to the findings, the trial did not meet the primary efficacy endpoint of a mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score, as the trial did not demonstrate a statistically significant difference between AVP-786 and the placebo.
The study also reported one treatment-emergent adverse event of a fall, with an incidence rate of over 5% in the AVP-786 arm.
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Falls were more common in subjects treated with AVP-786, with 16 in the high-dose group, 18 in the low-dose group, and six in the placebo group.
The company plans to conduct further prespecified and exploratory analyses of the data set to fully determine the drug’s potential for treating agitation linked to dementia in Alzheimer’s disease patients.
Otsuka executive vice-president and chief medical officer John Kraus said: “While the result of this trial is disappointing, we plan to analyse 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.
“In 2023, Otsuka became the first company to get a drug approved for this patient population and we are committed to expanding and innovating in this area.
“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.”
Last October, the company reported positive findings from two Phase III trials of centanafadine to treat attention-deficit/hyperactivity disorder (ADHD).