ALISO VIEJO, Calif.
June 11, 2012
Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for the study of AVP-923, an investigational drug for the treatment of agitation in patients with Alzheimer's disease (AD). The company plans to initiate a Phase II study evaluating AVP-923 during the third calendar quarter of 2012.
"This marks the fourth IND for the AVP-923 program, reflecting our belief that the unique dual sigma-1 and NMDA receptor pharmacology has significant potential," said
, MD, senior vice president of R&D at Avanir Pharmaceuticals. "With no approved treatments for agitation in patients with Alzheimer's disease, this remains an area of tremendous unmet medical need. We look forward to initiating our clinical research program later this year."
About the Study
The objectives of this proof of concept study are to evaluate the safety, tolerability, and efficacy of AVP-923 for treatment of agitation and other behavioral disturbances in Alzheimer's patients. The trial is a multicenter, randomized, double-blind, placebo-controlled study that is expected to enroll approximately 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 scale or NPI. Secondary outcome measures include measures of disease severity, cognition, activities of daily living, quality of life and caregiver strain. Standard safety assessments will also be conducted.
The filing of this IND represents the next step in Avanir's plan to develop AVP-923 for a broad array of neurological and psychiatric conditions.
About Behavioral Disturbances and Alzheimer's Disease
An estimated 5 million Americans have Alzheimer's disease (AD), a number that has doubled since 1980 and is expected to be as high as 16 million by 2050. AD is generally characterized by cognitive decline, impaired performance of daily activities, and behavioral disturbances. Behavioral and psychiatric symptoms develop in as many as 60% of community-dwelling dementia patients and in more than 80% of patients with dementia living in nursing homes; as the disease progresses the risk of such complications approaches 100%. Dementia-related behavioral symptoms, including agitation, can be extremely distressing to the individual, the family, and caregivers. These behavioral disturbances have been associated with more rapid cognitive decline, institutionalization, and increased caregiver burden.