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A combination of deudextromethorphan hydrobromide and quinidine sulfate (AVP-786; Avanir Pharmaceuticals, Alisa Viejo, CA) is being studied as potential treatment of moderate-to-severe agitation in patients with Alzheimer's dementia (AD) (NCT03393520). In preliminary data, patients treated with 1 of the 2 test doses of the combination had less agitation than those given placebo. Agitation was measured with the Cohen-Mansfield Agitation Inventory.
In this 12-week phase 3 trial, 410 patients with AD, age 50 to 90, were randomly assigned to receive placebo or 1 of 2 different doses of the combination for 6 weeks. After this initial period, those who had been receiving either dose of the drug continued taking it for another 6 weeks.
"These initial data from the first phase 3 study are encouraging and we look forward to continuing to evaluate AVP-786 for the treatment of moderate-to-severe agitation in patients with AD as the clinical program progresses," said Sanjay Dubé, MD, vice president, research & development, head of clinical development & scientific strategy, Avanir Pharmaceutical.
The combination therapy is also being investigated in patients with negative symptoms of schizophrenia and neurobehavioral disinhibition in traumatic brain injury.