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AVANIR Pharmaceuticals (AVNR) Provides Update on European Regulatory Filing for NUEDEXTA


7/26/2011 10:55:17 AM

ALISO VIEJO, Calif., July 26, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced several positive developments regarding its anticipated European regulatory filing of NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate) capsules for the treatment of pseudobulbar affect (PBA).

On July 22, 2011, company officials met with the European Medicines Agency (EMA) to discuss plans for filing a marketing authorization application (MAA) for NUEDEXTA for the treatment of PBA. Based on the outcome of the meeting, the company plans to request an accelerated review process and to file for approval of NUEDEXTA using the data package which served as the basis for the U.S. Food and Drug Administration approval of NUEDEXTA. The timing of the company's MAA filing is subject to reaching an agreement with the EMA on a pediatric investigation plan (PIP) for NUEDEXTA which may occur before the end of calendar year 2011.

In addition, the company also received notification from the EMA that NUEDEXTA can be filed for approval under the agency's centralized procedure. Filing under the centralized procedure provides for a single, coordinated review that is conducted by the EMA and results in a regulatory decision which is binding on all European Union member states. Centrally-authorized products may be marketed in all member states.

"PBA is a disabling neurologic condition affecting the lives of many people in Europe," said Professor Kevin Talbot, MBBS, DPhil, FRCP, Senior Clinical Lecturer in the Department of Clinical Neurology, and Director of the Motor Neuron Disease Care and Research Centre at University of Oxford. "As more resources are committed to understanding PBA in Europe, its prevalence and the importance of treating this disorder will be better appreciated. Meeting with the EMA is an important next step toward making a proven treatment like NUEDEXTA available to patients with this debilitating disorder."

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.

About NUEDEXTA

NUEDEXTA® is the first and only FDA-approved treatment for pseudobulbar affect (PBA). 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 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 patient's 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. The primary outcome measure, laughing and crying episodes, was significantly lower in the NUEDEXTA arm compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the NUEDEXTA arm compared to placebo.

NUEDEXTA Important Safety Information

NUEDEXTA can interact with other medications causing significant changes in blood levels of those

medications and/or NUEDEXTA. NUEDEXTA is contraindicated in patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. NUEDEXTA is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days. NUEDEXTA is contraindicated in patients with a known hypersensitivity to its components.

NUEDEXTA may cause serious side effects, including possible changes in heart rhythm. NUEDEXTA is contraindicated in patients with a prolonged QT interval, congenital long QT syndrome or a history suggestive of torsades de pointes, in patients with heart failure as well as patients with, or at risk of, complete atrioventricular (AV) block, unless the patient has an implanted pacemaker.

NUEDEXTA causes dose-dependent QTc prolongation. When initiating NUEDEXTA in patients at risk of QT prolongation and torsades de pointes, electrocardiographic (ECG) evaluation of QT interval should be conducted at baseline and 3-4 hours after the first dose.

The most common adverse reactions in patients taking NUEDEXTA are diarrhea, dizziness, cough, vomiting, weakness, swelling of feet and ankles, urinary tract infection, flu, elevated liver enzymes, 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.

Patients should take NUEDEXTA exactly as prescribed. Patients should not take more than 2 capsules in a 24- hour period, make sure that there is an approximate 12-hour interval between doses, and not take a double dose after they miss a dose.

These are not all the risks from use of NUEDEXTA. For additional important safety information about NUEDEXTA, please see the full Prescribing Information at www.NUEDEXTA.com.

AVANIR and NUEDEXTA® are trademarks owned by Avanir Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners

©2011 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 the accelerated review process, pediatric investigation plan, filing under the centralized procedure, 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 potential regulatory delays or rejections in the filing or acceptance of the Marketing Authorization Application, delay or failure to file under an accelerated review process, uncertainty regarding use of the data package which served as the basis for the U.S. Food and Drug Administration approval, delay or failure to reach an agreement on a pediatric investigation plan, uncertainty of the filing, review and approval process under a centralized procedure, 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.

SOURCE Avanir Pharmaceuticals, Inc.



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