Avanir Pharmaceuticals Announces Two Data Presentations Related to Pseudobulbar Affect (PBA) at the Alzheimer's Association Int

      Avanir Pharmaceuticals Announces Two Data Presentations Related to
    Pseudobulbar Affect (PBA) at the Alzheimer's Association International
                              Conference (AAIC)

PR Newswire

ALISO VIEJO, Calif., June 30, 2014

ALISO VIEJO, Calif., June 30, 2014 /PRNewswire/ -- Avanir Pharmaceuticals,
Inc. (NASDAQ: AVNR) today announced that data related to pseudobulbar affect
(PBA), a neurological condition characterized by disruptive, uncontrollable
episodes of laughing or crying, and NUEDEXTA® (dextromethorphan
hydrobromide/quinidine sulfate), the only FDA-approved product for the
treatment of PBA, will be presented at the Alzheimer's Association
International Conference (AAIC), being held at the Bela Center in Copenhagen,
Denmark, July 12-17, 2014.

Poster Presentation Details

Title: PRISM II: An Open-Label Study to Assess the Safety, Tolerability, and
Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg (NUEDEXTA) in
Pseudobulbar Affect (PBA) Secondary to Dementia, Stroke, or Traumatic Brain
Injury (TBI): Early Results of the Alzheimer's Disease/Dementia Cohort
Poster Number: 45758
Presentation Date/Time: Wednesday, July 16, 2014; 11:45 a.m. – 2:15 p.m. CET

Title: Prevalence and Correlates of Pseudobulbar Affect (PBA) Symptoms in
Nursing Home Residents
Poster Number: 45786
Presentation Date/Time: Wednesday, July 16, 2014; 11:45 a.m. – 2:15 p.m. CET

The objectives of the study are to evaluate the safety, tolerability, and
effectiveness of NUEDEXTA capsules containing 20 mg dextromethorphan (DM) and
10 mg quinidine (Q) for treatment of PBA in patients with prevalent
neurological conditions such as dementia, stroke and traumatic brain injury
over a 12 week period.

PRISM II is a nationwide, open-label, multicenter, 12-week study enrolling up
to approximately 450 patients at approximately 100 study centers. The
Alzheimer's disease/dementia cohort is fully enrolled at 134 patients.
Eligible patients are aged ≥18 years with a clinical diagnosis of PBA and
baseline score ≥13 on the Center for Neurologic Study-Lability Scale (CNS-LS),
a PBA rating instrument. Patients with TBI due to a penetrating head injury
are excluded. Patients are treated with DMQ 20/10 mg twice daily. The primary
endpoint is change from baseline in CNS-LS score. Determination of
effectiveness is based on a comparison of CNS-LS change in PRISM II with
results of previous Phase III studies. Additional outcomes measures include:
number of PBA episodes (laughing and/or crying); Mini-Mental State
Examination; quality of life; Clinician and Patient Global Impression (CGIC;
PGIC); patients' satisfaction with treatment; Patient Health Questionnaire
(PHQ-9) (to evaluate mood symptoms), and the Neurobehavioral Functioning
Inventory for TBI patients. Safety measures include monitoring of adverse
events, concomitant medication usage, and vital signs.

About the Nursing Home Study
This study evaluated the prevalence and correlates of PBA symptoms in a sample
of US nursing home residents. 810 residents across 9 nursing homes in Michigan
were screened and their charts reviewed. The analysis population was the
subset of nursing home residents having a neurological diagnosis. Clinical
assessments included the CNS-LS and a PBA diagnostic checklist.

About PBA
PBA is a neurologic condition characterized by uncontrollable, disruptive
laughing and/or crying outbursts that are often contrary or exaggerated to the
patient's inner mood state. As a result, many of those afflicted with PBA show
significant impairment on standard measures of health status, and impairments
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),amyotrophic lateral sclerosis (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 visitwww.pbafacts.com

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

NUEDEXTA is an innovative combination of two well-characterized components;
dextromethorphan hydrobromide (20 mg), the ingredient active in the central
nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling
therapeutic dextromethorphan concentrations. NUEDEXTA acts on sigma-1 and NMDA
receptors in the brain, although the mechanism by which NUEDEXTA exerts
therapeutic effects in patients with PBA is unknown.

NUEDEXTA Important Safety Information
NUEDEXTA is indicated for the treatment of pseudobulbar affect (PBA). PBA
occurs secondary to a variety of otherwise unrelated neurological conditions,
and is characterized by involuntary, sudden, and frequent episodes of laughing
and/or crying. PBA episodes typically occur out of proportion or incongruent
to the underlying emotional state.

Studies to support the effectiveness of NUEDEXTA were performed in patients
with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). NUEDEXTA
has not been shown to be safe and effective in other types of emotional
lability that can commonly occur, for example, in Alzheimer's disease and
other dementias.

NUEDEXTA and certain other medicines can interact, causing serious side
effects. If you take certain drugs or have certain heart problems, NUEDEXTA
may not be right for you.

NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in
patients at risk for QT prolongation and torsades de pointes,
electrocardiographic (ECG) evaluation should be conducted at baseline and 3-4
hours after the first dose.

The most common adverse reactions are diarrhea, dizziness, cough, vomiting,
asthenia, peripheral edema, urinary tract infection, influenza, increased
gamma-glutamyltransferase, and flatulence. NUEDEXTA may cause dizziness.

These are not all the risks from use of NUEDEXTA. Please refer to full
Prescribing Information at www.NUEDEXTA.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® and NUEDEXTA® are registered trademarks owned by Avanir
Pharmaceuticals, Inc. All other trademarks are the property of their
respective owners.

©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, the market demand for and acceptance of Avanir's products domestically
and internationally, research, development and commercialization of new
products domestically and internationally, including the risks and
uncertainties associated with meeting the objectives of the study of NUEDEXTA
in the PRISM II study including, but not limited to, risks relating to delays
or failures in enrollment, or delays in the release of study results,
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
+1 (949) 389-6700

Brewlife Media Contact
Kelly France
+1 (415) 946-1076

Avanir Pharmaceuticals, Inc.

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SOURCE Avanir Pharmaceuticals, Inc.

Website: http://www.avanir.com
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