Avanir Pharmaceuticals has completed patient enrolment in its placebo-controlled Phase II trial evaluating safety, tolerability and efficacy of AVP-923 for the treatment of agitation in patients with Alzheimer’s disease (AD).
A total of 220 Alzheimer’s patients in the US were enrolled in the multicentre, randomised, double-blind, placebo-controlled Phase II trial.
In the trial, eligible patients were given either AVP-923 (dose escalated from DM 20mg/ Q 10mg to DM 30mg/ Q 10mg) or placebo for ten weeks.
The trial’s secondary outcome measures include global assessments of disease severity, other neuropsychiatric symptoms, cognition, activities of daily living, quality of life and caregiver strain.
The company said that standard safety assessments will also be conducted and it expects to release top-line results from the trial in late September or early October of 2014.
Avanir chief medical officer Joao Siffert said final completion of enrolment in the trial is an important milestone for the company as it explores the therapeutic utility of AVP-923, and later AVP-786 for the management of neuropsychiatric manifestations of neurological disease, including agitation.
"We are looking forward to the results from this study to potentially help guide the Phase III development of AVP-786 for the treatment of agitation in patients with Alzheimer’s disease," Siffert said. "AVP-786 is our next-generation investigational product containing deuterium modified dextromethorphan and ultra-low dose quinidine."
AVP-923 is a combination of two well-characterised compounds, the active CNS ingredient dextromethorphan hydrobromide plus low-dose quinidine sulfate, which serves to increase the bioavailability of dextromethorphan.
It is currently being evaluated in several ongoing company sponsored Phase II clinical trials including agitation in Alzheimer’s disease, levodopa-induced dyskinesia in Parkinson’s disease, and multiple investigator initiated studies.