Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the enrollment of the first patient in study AVR-131. The study is a Phase II clinical trial investigating the use of AVP-923 for the treatment of agitation in patients with Alzheimer's disease.
"Alzheimer's disease can cause a person to exhibit marked behavioral changes that are difficult for caregivers to manage. These symptoms can include agitation, hostility, anger, and aggression, with most patients exhibiting some or all of these symptoms during the course of the disease," said Jeffrey Cummings, MD, Professor of Neurotherapeutics and Drug Development in the Neurological Institute, Cleveland Clinic. "As the disease progresses, behavioral symptoms often increase in frequency and severity. With no approved therapies for agitation associated with dementia, managing these symptoms can be challenging. This trial is an important initial step in potentially providing a therapy to help manage symptoms of agitation in Alzheimer's disease."
The objectives of this proof of concept study are to evaluate the safety, tolerability, and efficacy of AVP-923 for the treatment of agitation in Alzheimer's patients. The trial is a multicenter, randomized, double-blind, placebo-controlled study that is expected to enroll up to 200 Alzheimer's patients in the United States. Eligible patients will be randomized to receive either AVP-923 or placebo for 10 weeks. The main efficacy measure is the Neuropsychiatric Inventory or NPI. Secondary outcome measures include assessments of disease severity, behavioral abnormalities, cognition, activities of daily living, quality of life and caregiver strain. Standard safety assessments will also be conducted.
Jeffrey Cummings, MD is a paid consultant of Avanir Pharmaceuticals, Inc. In addition, Dr. Cummings is the inventor of the Neuropsychiatric Inventory and receives royalties for its use.
Avanir Pharmaceuticals, Inc.