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
About PRISM II
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
visit www.pbafacts.com
The CNS-LS has been validated in ALS and MS patients.
About NUEDEXTA
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
ir@avanir.com
+1 (949) 389-6700
Brewlife Media Contact
Kelly
France
kfrance@brewlife.com
+1 (415) 946-1076
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SOURCE Avanir Pharmaceuticals, Inc.