Avanir Pharmaceuticals Receives Positive CHMP Opinion for Approval of NUEDEXTA
NUEDEXTA recommended for the treatment of PBA, irrespective of neurologic
ALISO VIEJO, Calif., April 26, 2013
ALISO VIEJO, Calif., April 26, 2013 /PRNewswire/ --Avanir Pharmaceuticals,
Inc. (NASDAQ: AVNR) today announced that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion for NUEDEXTA^® (dextromethorphan hydrobromide and quinidine
sulfate), recommending NUEDEXTA be approved for the treatment of pseudobulbar
affect (PBA), irrespective of neurologic cause. In addition, the CHMP also
recommended approval of two dose strengths of NUEDEXTA; 20/10 mg and 30/10 mg
"The positive opinion from CHMP and recommendation for a broad PBA label for
NUEDEXTA is a key step in the regulatory process toward having the first and
only evidence-based treatment for PBA approved in the European Union," said
Dr. Joao Siffert, chief scientific officer of Avanir. "We will continue to
work with the European Medicines Agency and the European Commission toward the
marketing authorization so that patients suffering from PBA have ready access
to NUEDEXTA in Europe."
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 (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.
"PBA causes substantial medical and social burden," said Professor Kevin
Talbot, director of the Oxford Motor Neuron Disease Care & Research Center.
"Appropriate management of this debilitating condition can have meaningful
clinical benefits for patients. Once available in Europe, NUEDEXTA will offer
an important therapeutic option to effectively manage PBA."
The European Commission, which has the authority to approve medicines for use
in the European Union, generally follows the recommendations of the CHMP and
typically renders a final decision within three months of the CHMP opinion. If
the CHMP recommendation is formally adopted by the European Commission,
NUEDEXTA would be approved for marketing in all 27 member states of the
European Union plus Iceland and Norway.
For further details about the CHMP opinion, please visit the EMA website.
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 in the 20/10 mg dose
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^® and NUEDEXTA^® are trademarks or registered trademarks 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.