Avanir Pharmaceuticals Announces Publication Of PBA Burden Of Illness Study

ALISO VIEJO, Calif., Sept. 5, 2012 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) announced today that Advances in Therapy published results from a U.S. survey conducted by Harris Interactive, comparing Quality of Life (QOL), Quality of Relationships (QOR), health status and daily function of neurologic patients with and without symptoms of pseudobulbar affect (PBA). A link to the online article can be accessed at http://www.advancesintherapy.com/.

"The results from this survey demonstrate that PBA symptoms are associated with considerable burden incremental to that of the underlying neurological conditions, affecting quality of life and relationships, health status, and social and occupational functioning," said Randall Kaye, MD, chief medical officer at Avanir Pharmaceuticals. "This important information will help healthcare practitioners better appreciate and understand the multi-faceted impact of PBA symptoms on patients and their caregivers."

About the Study
An online survey was administered to neurologic patients across six underlying conditions commonly associated with PBA: Alzheimer's disease and other dementias, amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease, stroke, and traumatic brain injury. The 1,052 respondents included 399 PBA group participants who scored 13 or greater on the Center for Neurologic Study Lability Scale and 653 matched neurologic controls. In order to measure various aspects of burden of illness in PBA group respondents and controls, a series of medically validated scales were administered, including:

• The 36-Item Short Form Health Survey (SF-36)
• QOL and QOR visual analog scales measuring impact of involuntary laughing or crying episodes
• The Work Productivity and Activity Impairment (WPAI) Questionnaire: General Health V2.0
• The Center for Epidemiologic Studies Depression Scale 10-item short form (CES-D10)
• The Screen for Caregiver Burden (SCB)

The PBA group reported significantly worse scores versus non-PBA controls on the SF-36 health survey (P < 0.05 for all physical and mental component and summary scores), QOL and QOR visual analog scales (P < 0.05 for both), and workplace productivity items (P ≤ 0.05). Most patients in the PBA group and over half in the control group had significant depressive symptoms as determined by a CES-D10 scale score of 10 or greater (87% PBA group vs. 56% controls; P < 0.05). PBA symptoms contributed a great deal or were the main cause of becoming housebound for 24% and placement in supervised living for 9% of PBA group respondents. In addition, caregiver burden prevalence and distress scores were higher among caregivers in the PBA group (13.7 and 41.5, respectively; P = 0.05) compared with the control group (10.2 and 37.6, respectively; P = 0.05).

This study found that patients and primary caregivers of patients with PBA symptoms suffer significantly increased burden of illness compared with patients and caregivers of patients with the same underlying neurological conditions but without PBA symptoms. PBA group patients showed significantly greater impairment on measures of general health status, occupational and social function, and a significantly higher incidence of depressive symptoms than controls, both across and within primary neurological disease groups.  Inappropriate laughing/crying episodes were associated with feelings of embarrassment, frustration, and the potential for withdrawal and isolation.

About Pseudobulbar Affect
People with pseudobulbar affect (PBA) have sudden outbursts of involuntary crying or laughing, even though there may not be anything particularly sad or funny to trigger those emotions. Many people who suffer from PBA describe their episodes as uncontrollable, exaggerated, or different from their true feelings. PBA may occur when certain neurologic diseases or injury damage the areas of the brain that control normal expression of emotion. This damage can disrupt brain signaling, causing a "short circuit" and triggering episodes of involuntary crying or laughing. PBA can occur in people diagnosed with a variety of otherwise unrelated neurologic conditions such as Lou Gehrig's disease (ALS), multiple sclerosis (MS), Parkinson's disease, stroke, traumatic brain injury (TBI), and Alzheimer's disease. For more information about PBA, please visit www.PBAinfo.org.

About Harris Interactive
Harris Interactive is one of the world's leading custom market research firms, leveraging research, technology, and business acumen to transform relevant insight into actionable foresight. Known widely for The Harris Poll and for pioneering innovative research methodologies, Harris offers expertise in a wide range of industries including healthcare, technology, public affairs, energy, telecommunications, financial services, insurance, media, retail, restaurant, and consumer package goods. Serving clients in over 215 countries and territories through our North American, European, and Asian offices and a network of independent market research firms, Harris specializes in delivering research solutions that help us - and our clients - stay ahead of what's next. For more information, please visit www.harrisinteractive.com.

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 Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development 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 risks and uncertainties associated with Avanir's operating performance and financial position, the market demand for and acceptance of Avanir's products domestically and internationally, research, development and commercialization of new products domestically and internationally, obtaining and maintaining regulatory approvals domestically and internationally, the validity and enforceability of issued and pending patents, risks associated with meeting the objectives of any planned clinical study, including, but not limited to, delays or failures in enrollment, and the occurrence of adverse safety events, risks associated with being unable to raise PBA awareness amongst patients and physicians, 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, Ph
[email protected] 
+1 (949) 389-6700

SOURCE Avanir Pharmaceuticals, Inc.