Avanir Pharmaceuticals Announces European Approval of NUEDEXTA
ALISO VIEJO, Calif., June 25, 2013
ALISO VIEJO, Calif., June 25, 2013 /PRNewswire/ --Avanir Pharmaceuticals,
Inc. (NASDAQ: AVNR) today announced that the European Commission has approved
NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) in the European
Union for the treatment of pseudobulbar affect (PBA), irrespective of
underlying neurologic disease or injury.
"The approval of NUEDEXTA by the European Commission is a major breakthrough
for people with PBA who, until now, have had no EMA approved medications
indicated to treat this debilitating disorder," said Joao Siffert, MD, chief
scientific officer at Avanir. "NUEDEXTA addresses a genuine unmet patient need
and demonstrates Avanir's commitment to bringing innovative treatments to
people in Europe and throughout the world."
PBA is a neurologic condition characterized by outbursts of uncontrollable
crying or laughing 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 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, multiple sclerosis, amyotrophic lateral sclerosis (Lou Gehrig's
disease), 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.
NUEDEXTA is an innovative combination of two well-characterized components;
dextromethorphan hydrobromide, the ingredient active in the central nervous
system, and quinidine sulfate, 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 is approved in the U.S. for the treatment of PBA with a 20/10 mg dose
strength. NUEDEXTA is now approved in all 27 member states of the European
Union, plus Iceland and Norway, for the treatment of PBA with a 20/10 mg and
30/10 mg dose strength.
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 evaluated 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^® is a trademark or registered trademark of Avanir Pharmaceuticals,
Inc. in the United States and other countries.
^©2013 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, including, but not
limited to potential regulatory delays or rejections in the filing or
acceptance of the Marketing Authorization Application 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
SOURCE Avanir Pharmaceuticals, Inc.
Press spacebar to pause and continue. Press esc to stop.