(By Balaseshan) Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) said its Investigational New Drug (IND) application for the study of AVP-923, a drug for the treatment of agitation in patients with Alzheimer's disease (AD), was accepted by the U.S. Food and Drug Administration (FDA).
The company intends to initiate a Phase 2 study evaluating AVP-923 during the third calendar quarter of 2012. 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.
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 about 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.
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.
AVNR is trading up 4.46% at $3.04 on Monday. The stock has been trading between $1.77 and $4.18 for the past 52 weeks.