Avanir Pharmaceuticals Announces FDA Acceptance Of IND For AVP-923 For The Treatment Of Agitation In Patients With Alzheimer's Disease
"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
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 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.
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Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the initiation of a Phase II clinical trial are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the ability to recruit clinical investigator sites, the ability to enroll patients into the clinical trial, the ability to commence clinical studies within expected timelines, the success of these clinical studies, and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the
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