ALISO VIEJO, Calif.,
March 19, 2014 /PRNewswire/
-- 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.
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 additional
indications for commercially marketed products domestically and
internationally, obtaining and maintaining regulatory approvals
domestically and internationally, 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
Joey Fleury, BrewLife
jfleury@brewlife.com
+1 (415) 946-1090
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SOURCE Avanir Pharmaceuticals, Inc.