Navigation Links
Avanir Pharmaceuticals Announces Paragraph IV ANDA Filing for NUEDEXTA

ALISO VIEJO, Calif., July 1, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the U.S. Food and Drug Administration (FDA) website indicates that an Abbreviated New Drug Application (ANDA) for a generic version of NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate) capsules was submitted on March 7, 2011. The company received Paragraph IV certification notices on June 30, 2011.

Avanir intends to vigorously enforce its intellectual property rights relating to NUEDEXTA, which is protected by several patents covering the method of use of the product and its formulation. All of the currently issued patents are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Under the FDA's rules and regulations, if Avanir initiates a patent infringement suit to defend the patents identified in any Paragraph IV notice it receives within 45 days after its receipt of such notice, the FDA is prevented from approving the ANDA until the earlier of: (1) 30 months; (2) the expiration of the patents at issue; or (3) a decision in the infringement case that all of such patents are not infringed or invalid.

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


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

AVANIR™ is a trademark 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 defense of Avanir's patent rights and the potential success of defending against a generic challenge 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 ability to successfully defend the intellectual property rights relating to NUEDEXTA, 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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. AVANIR Pharmaceuticals Invites Investors to Fiscal 2010 Third Quarter Conference Call
2. AVANIR Pharmaceuticals to Present at the UBS Global Life Sciences Conference
3. AVANIR Pharmaceuticals Announces FDA Approval of NUEDEXTA™
4. AVANIR Pharmaceuticals Invites Investors to Conference Call Regarding FDA Approval of NUEDEXTA™ on Monday November 1, 2010
5. AVANIR Pharmaceuticals Announces Pricing of Public Offering of Common Stock
6. AVANIR Pharmaceuticals Announces NASDAQ Opening Bell Ceremony
7. AVANIR Pharmaceuticals Invites Investors to Fiscal 2011 First Quarter Conference Call
8. AVANIR Pharmaceuticals Announces Fiscal 2011 First Quarter Financial Results
9. AVANIR Pharmaceuticals Appoints Gregory J. Flesher to Senior Vice President and Chief Business Officer
10. Avanir Pharmaceuticals to Present at Three Conferences in March
11. Avanir Pharmaceuticals to Present at BioCentury Future Leaders in the Biotech Industry Conference
Post Your Comments:
(Date:11/30/2015)... Nuance Communications, Inc. (NASDAQ: NUAN ) and ... today jointly announced a new integrated set of clinical ... College of Radiology,s (ACR) Imaging 3.0™ tools to enable ... current and emerging value-based payment models . ... clinical decision support, radiology reporting and image sharing technology ...
(Date:11/30/2015)... HYDERABAD, India , Nov. 30, 2015 Varian Medical ... (MoU) to develop an educational partnership with Apollo Hospitals Group, the ... a program that will help train radiation technologists in the country. ... executive officer of Apollo Knowledge, and Ashok Kakkar , Varian,s ... . India , Varian intends ...
(Date:11/30/2015)... Belgium , Nov. 30, 2015   VolitionRx ... on developing blood-based diagnostic tests for a broad range of ... present at the LD Micro Conference, which will be held ... Attending from VolitionRx will be David Kratochvil ... , Vice President of Investor Relations. ® ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... Using a combination of two ... American children and adults, according to a new study by researchers at the School ... in Children and Adults: Using Combinations of Blood Glucose Tests ,” published in Frontiers ...
(Date:11/30/2015)... ... 30, 2015 , ... The recently published 32nd Annual Report ... reveals that in 2014, someone called a poison center about every 11 seconds. ... were human exposure cases. , The American Association of Poison Control Centers (AAPCC) ...
(Date:11/30/2015)... PA (PRWEB) , ... November 30, 2015 , ... ... Specialty Ingredients (ASI) as their exclusive channel partner for the Nutraceutical Specialties products ... markets in the US, effective immediately. , “We are pleased to announce ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... announced at the Radiology Society of North America (RSNA) annual meeting, being held ... 60% growth from 2014. Throughout 2015, the company has completed installations for ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... Kreithen”), one of the leading plastic surgery practices in Florida, is proud to ... to consult for surgical innovations giant Ethicon Inc., a Johnson & Johnson Company. ...
Breaking Medicine News(10 mins):