ALISO VIEJO, Calif.,
Aug. 11, 2015 /PRNewswire/ --
Avanir Pharmaceuticals, Inc. today announced that a panel of
the U.S. Court of Appeals for the Federal Circuit has upheld the
validity and enforceability of Avanir's patents covering NUEDEXTA
(U.S. Patent Nos. 7,659,282 (the '282' patent) and 8,227,484 (the
'484' patent)). The decision confirms patent protection for
NUEDEXTA until 2026 in the United
States.
The Appeals Court ruling affirmed the April 2014 decision upholding the '282' and '484'
patents' validity by the U.S. District Court for the District of
Delaware in a lawsuit brought by
Avanir against the generic manufacturers Par Pharmaceuticals, Inc.
and Impax Laboratories, Inc.
"We are very pleased with the outcome of the appeal providing
market exclusivity for NUEDEXTA for another eleven-plus years.
Thousands of patients have benefited from NUEDEXTA since its launch
in 2011 and this decision gives us the opportunity to continue
helping those suffering from pseudobulbar affect (PBA) for many
years to come," said Keith A.
Katkin, president and chief executive officer of Avanir.
NUEDEXTA remains the only FDA-approved product for the treatment
of PBA.
About NUEDEXTA
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. Dextromethorphan 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 neurologic
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. PBA is a specific condition, distinct from other types of
emotional lability that may occur in patients with neurological
disease or injury.
NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate)
20mg/10mg capsules can interact with other medications causing
significant changes in blood levels of those medications and/or
NUEDEXTA which may lead to serious side effects. Adjust dose of the
other medication or use alternate treatment when clinically
indicated.
NUEDEXTA is contraindicated in patients concomitantly taking:
QT-prolonging drugs metabolized by CYP2D6 (e.g., thioridazine and
pimozide); monoamine oxidase inhibitors (MAOIs) within the
preceding or following 14 days; other drugs containing quinidine,
quinine, or mefloquine and in patients with a known
hypersensitivity to these drugs or any of NUEDEXTA's
components.
Discontinue use of NUEDEXTA if hepatitis, thrombocytopenia,
serotonin syndrome or a hypersensitivity reaction occurs.
NUEDEXTA is contraindicated in patients with certain risk
factors for arrhythmia: Prolonged QT interval; congenital long QT
syndrome, history suggestive of torsades de pointes; heart failure;
complete atrioventricular (AV) block or risk of AV block without an
implanted pacemaker.
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. Risk factors
include left ventricular hypertrophy or dystrophy or concomitant
use of drugs that prolong QT interval or certain CYP3A4
inhibitors.
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. Precautions to reduce the
risk of falls should be taken, particularly for patients with motor
impairment affecting gait or a history of falls.
These are not all the risks from use of NUEDEXTA®. Please refer
to the 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 http://www.avanir.com.
Avanir is a subsidiary of Otsuka
America, Inc. (OAI), a holding company established in the
U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co.,
Ltd., a global healthcare company with the corporate philosophy:
'Otsuka-people creating new products for better health
worldwide.'
Otsuka Pharmaceutical is a leading firm in the challenging area
of mental health and also has products and research programs for
several under-addressed diseases including tuberculosis, a
significant global public health issue. These commitments
illustrate more powerfully than words how Otsuka is a "big venture"
company at heart, applying a youthful spirit of creativity in
everything it does.
Otsuka Pharmaceutical and its affiliates employ approximately
30,000 people globally, and the company welcomes you to visit its
global website at: http://www.otsuka.co.jp/en/index.php
Avanir® is a trademark or registered trademark of Avanir
Pharmaceuticals, Inc. in the United
States and other countries.
©2015 Avanir Pharmaceuticals, Inc. All Rights Reserved.
BrewLife Media Contact
Nicole
Foderaro
nfoderaro@brewlife.com
+1 (415) 946-1058
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SOURCE Avanir Pharmaceuticals, Inc.