Avanir Pharmaceuticals Announces Patient Assistance Program For NUEDEXTA

ALISO VIEJO, Calif., June 5, 2012 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced details of its Patient Assistance Program for NUEDEXTA® (dextromethorphan HBr and quinidine sulfate). The Patient Assistance Program is designed to help patients with a diagnosis of pseudobulbar affect which meet established program criteria gain access to NUEDEXTA free of charge.

"NUEDEXTA is the first and only FDA approved medication indicated for pseudobulbar affect. Avanir's goal is to ensure that cost is not a barrier to any person who may benefit from this important medication, regardless of their level of income or healthcare coverage," said Rohan Palekar, chief commercial officer at Avanir Pharmaceuticals. "To that end, we are pleased to offer this new Patient Assistance Program as part of our comprehensive offering of patient support services."

This new program complements two other existing financial assistance programs currently available for patients insured by commercial health plans or Medicare Part D. With the addition of the Patient Assistance Program for patients without prescription drug coverage, Avanir now offers financial assistance for most people needing access to NUEDEXTA.

The new program, which launched in May 2012, provides eligible patients with a 6-month supply of drug, free of charge to help ensure access to NUEDEXTA. Program participants may qualify for ongoing assistance subject to periodic verification of eligibility.

NUEDEXTA Patient Services
The Patient Assistance Program is available as part of the services provided under NUEDEXTA Patient Services for patients and healthcare providers. The service provides necessary financial and treatment support for NUEDEXTA in one single point of contact. The services include:

  • Health insurance plan assistance, including drug benefit verification
  • Financial and co-pay assistance for eligible insured and uninsured patients
    • Co-pay Assistance Program for privately insured patients
    • Out-of-pocket Assistance Program for Medicare Part D patients
    • Patient Assistance Program for patients without prescription drug coverage
  • Educational information about PBA and NUEDEXTA

NUEDEXTA Patient Services is available by calling 1-855-4NUEDEX (468-3339). Hours of operation are 9 a.m. to 7 p.m. ET, Monday-Friday. Additional information is also available online at http://www.nuedexta.com.

About Pseudobulbar Affect
People with pseudobulbar affect (PBA) have sudden outbursts of involuntary crying or laughing, even though there may not be anything particularly sad or funny to trigger those emotions. Many people who suffer from PBA describe their episodes as uncontrollable, exaggerated, or different from their true feelings. PBA may occur when certain neurologic diseases or injury damage the areas of the brain that control normal expression of emotion. This damage can disrupt brain signaling, causing a "short circuit" and triggering episodes of involuntary crying or laughing. PBA can occur in people diagnosed with a variety of otherwise unrelated neurologic conditions such as Lou Gehrig's disease (ALS), multiple sclerosis (MS), Parkinson's disease, stroke, traumatic brain injury (TBI), and Alzheimer's disease. For more information about PBA, please visit www.PBAinfo.org.

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 (dextromethorphan hydrobromide and quinidine sulfate) 20/10 mg 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 or use alternate treatment of the other medication 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 accompanying full Prescribing Information or visit 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.

©2012 Avanir Pharmaceuticals, Inc. All Rights Reserved.

Avanir Investor & Media Contact
Ian Clements, PhD
+1 (949) 389-6700

SOURCE Avanir Pharmaceuticals, Inc.