Avanir Pharmaceuticals Presents Data From A Benchmark Study Of PBA Symptoms In Veterans With Mild Traumatic Brain Injury

Majority of Responding Veterans Surveyed Report Having PBA Symptoms, Adding an Extra Burden to Managing Life Post-TBI

Aliso Viejo, CA (PRNewswire) March 19, 2014 -Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the presentation of results from a first-of-its-kind study of pseudobulbar affect (PBA) symptoms in veterans with mild traumatic brain injury (TBI) conducted in collaboration with the Department of Veterans Affairs (VA) and Evidera. The study will be presented at the Tenth World Congress on Brain Injury in San Francisco on Friday March 21, 2014.

"It is estimated that between 12 and 23 percent of service members deployed to Iraq and/or Afghanistan have sustained a traumatic brain injury and this study suggests that many of these men and women may also be suffering from PBA, a distressing neurological condition marked by uncontrollable, disruptive episodes of crying or laughing," said Dr. Regina McGlinchey, director of the Translational Research Center for TBI and Stress Disorders, a VA Rehabilitation Research &Development Service, TBI Center of Excellence at VA Boston Healthcare System. "More than half of responders from our study reported that they are experiencing symptoms of PBA. Those with PBA symptoms reported significantly worse health-related quality of life scores, and there appeared to be a high correlation between PBA symptoms and post-traumatic stress disorder (PTSD)."

Highlights from the cross sectional survey results of 4,283 patients within the VA system include:

• 758 (19 percent) veterans with TBI responded to the survey an unusually high response rate for similar studies.
• 60 percent of respondents reported PBA symptoms, characterized by the presence of involuntary, uncontrollable episodes of crying and/or laughing that were exaggerated or even contrary to how they felt at the time.
  • In contrast, other commonly perceived challenges faced by veterans were reported less frequently, including: PTSD (48 percent) major depression (31%) and anxiety disorders (18%).
• Veterans who suffer from PBA symptoms were more likely to also suffer from PTSD, a finding not previously understood or recognized.
  • Among veterans with scores ≥13 in the Center for Neurologic Study-Lability Scale (CNS-LS), denoting PBA symptoms, 54 percent reported suffering from PTSD versus approximately 32 percent of CNS-LS negative veterans.
• In terms of measuring overall health status, those that suffered from PBA symptoms scored lower on the EQ-5D index (an international, standardized, general measure of health status) suggesting that they have an extra burden impacting their quality of life.
  • More than 94 percent of CNS-LS positive Veterans report at least some problems with pain/discomfort or anxiety/depression, the majority of whom had symptoms of at least moderate severity.
• Veterans who suffer from PBA symptoms were also significantly more likely to be on antidepressants than those without PBA symptoms.
  • 46 percent of CNS-LS positive veterans reported being on antidepressants versus approximately 31 percent of CNS-LS negative veterans

"Results from this benchmark study suggest a high prevalence of PBA symptoms among veterans with mild traumatic brain injuries, an issue that significantly compounds the burden on veterans as more troops reintegrate into society after active service," said Joao Siffert, M.D., chief medical officer at Avanir. "Our ultimate goal with this research is to collaborate with the VA to develop a screening protocol for identifying PBA symptoms to help improve diagnosis, treatment and ultimately the quality of care for our nation's veterans. Additionally, understanding the interplay between PBA and other brain injury neuropsychiatric consequences may help guide a more specific and comprehensive approach to patient care."

Poster Presentation Details
Title: Study of Pseudobulbar Affect Symptoms in Veterans with Mild Traumatic Brain Injury
Abstract/Poster Number: 0742 (Poster Session 3)
Presentation Date/Time: Friday, March 21, 9:30-10:30 a.m. Pacific Time

About the Study
A screening questionnaire was sent to approximately 4,283 people within the VA system in the Boston area who were identified as having a TBI. The questionnaire consisted of an initial question  asking if the veteran has ever experienced "involuntary episodes of crying and/or laughing that were exaggerated or even contrary to how they felt at the time," as well as the seven-item Center for Neurologic Study-Lability Scale (CNS-LS). The EQ-5D questionnaire, an international, standardized, general measure of health status was also included to evaluate health-related quality of life (HRQOL). The presence of PBA symptoms were determined based on positive response to the "involuntary episodes" question or a CNS-LS score >13. Demographic and clinical characteristics of respondents, as well as HRQOL scores, were compared between those with and without PBA symptoms. Completed surveys were matched to the medical records of respondents to assess demographics, co-morbid conditions and health resource utilization, including medications.

About Traumatic Brain Injury in the Military
TBI is widely regarded as the "signature wound" of the Iraq and Afghanistan wars, accounting for 22 percent of all injuries and 59 percent of blast-related injuries. Based on existing data, veterans' advocates believe that between 12 and 23 percent of Iraq veterans, or 150,000 to 300,000 people, have some level of TBI. Among wounded troops, the rate of TBI rises to 33 percent. In the past decade, more than 230,000 American soldiers were diagnosed with TBI.

About PBA
PBA is a neurologic condition characterized by emotional outbursts that are often contrary or exaggerated to the patient's inner mood state, causing them to laugh or cry uncontrollably. As a result, many of those afflicted with PBA show significant impairment on standard measures of health status, and disruption in occupational and social function, often leading to social isolation. PBA occurs secondary to a variety of neurologic conditions such as traumatic brain injury (TBI), multiple sclerosis (MS), Lou Gehrig's disease (ALS), Parkinson's disease, stroke and Alzheimer's disease. When these disorders damage areas of the brain that regulate normal emotional expression, they can lead to uncontrollable, disruptive episodes of crying or laughing. For more information about PBA, please visit www.pbafacts.com.

The CNS-LS has only been validated in ALS and MS patients.

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.

©2014 Avanir Pharmaceuticals, Inc. All Rights Reserved.

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