Avanir Pharmaceuticals Prevails in NUEDEXTA® Patent Appeal Maintaining Exclusivity Through 2026

Aug 11, 2015, 08:30 ET from Avanir Pharmaceuticals, Inc.

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.

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SOURCE Avanir Pharmaceuticals, Inc.



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