Avanir Pharmaceuticals Announces FDA Acceptance Of IND For AVP-923 For The Treatment Of Agitation In Patients With Alzheimer's Disease 200 Patient Phase II Clinical Trial to Begin by September 2012

ALISO VIEJO, Calif., June 11, 2012 /PRNewswire/ -- 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 Joao Siffert, 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.

About Avanir Pharmaceuticals, Inc.

Avanir Pharmaceuticals, Inc. is a biopharmaceutical Company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.

AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries.

©2012 Avanir Pharmaceuticals, Inc. All Rights Reserved.

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 Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Avanir Investor & Media Contact
Ian Clements, PhD
ir@avanir.com
+1 (949) 389-6700

SOURCE Avanir Pharmaceuticals, Inc.



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