Navigation Links
Avanir Pharmaceuticals Files Lawsuits Against Par and Actavis for Infringement of NUEDEXTA Patents
Date:8/11/2011

ALISO VIEJO, Calif., Aug. 11, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that it has filed lawsuits in the U.S. District Court for the District of Delaware against Par Pharmaceutical, Inc. and Par Pharmaceutical Companies, Inc (collectively "Par") and Actavis South Atlantic LLC and Actavis, Inc. (collectively "Actavis").  

The lawsuits were filed in response to Abbreviated New Drug Applications ("ANDAs") filed by Par and Actavis.  In their applications, Par and Actavis seek to market and sell generic versions of the currently approved dose of NUEDEXTA® prior to the expiration of U.S. patents 7,659,282 and RE38,115 (which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations ("Orange Book")).  Avanir filed the lawsuits on the basis that Par's and Actavis' proposed generic products infringe certain patents held by Avanir.

In accordance with the Hatch-Waxman Act, as a result of having filed lawsuits within 45 days of the Paragraph IV certification notices, FDA approval of the ANDAs will be stayed until the earlier of (i) 30 months from the Company's receipt of the notices or (ii) a District Court decision finding that the identified patents are invalid, unenforceable or not infringed.

Avanir intends to vigorously enforce its patent rights.

For a discussion of risks related to the ANDA filing, see the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 filed by the Company on August 9, 2011.

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 or registered trademarks of Avanir Pharmaceuticals, Inc. in the United States and other countries.  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 Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development 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 risks and uncertainties associated with litigation, including, but not limited to Avanir's ability to protect its patents and other intellectual property, 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:
*Name:
*Comment:
*Email:
(Date:6/13/2017)... WARSAW, Ind. , June 13, 2017 Zimmer ... in musculoskeletal healthcare, today announced that the U.S. Food and ... Letter dated June 3, 2015 relating to its ... "The successful clearance of ... China manufacturing facility is a measure of the ...
(Date:6/9/2017)... INDIANAPOLIS , June 9, 2017 /PRNewswire/ ... diabetes. In a further effort to help spread lessons ... this condition, the International Diabetes Federation (IDF) and Eli ... come together for the second phase of the Bringing ... (BRIDGES 2), reaffirming their commitment to helping people with ...
(Date:6/7/2017)... June 7, 2017  Novavax, Inc., (Nasdaq: NVAX ... Phase 2 trials of its RSV F protein recombinant nanoparticle ... age have been published in the journal Vaccine ... shared in prior scientific conferences). The Company previously announced ... Novavax is developing the RSV F Vaccine with the goal ...
Breaking Medicine Technology:
(Date:6/25/2017)... ... June 25, 2017 , ... CareSet Labs released the ... New Orleans. This is a new, greatly improved version of the Doctor Referral teaming ... requests by Fred Trotter and subsequently called the the “Doctor Referral Dataset” as released ...
(Date:6/24/2017)... (PRWEB) , ... June 24, 2017 , ... ... Dental365 family. Located at 217 Portion Road in Lake Ronkonkoma, Dental365 offers patients ... and weekends so that visits to the dentist fit into their patients’ busy ...
(Date:6/23/2017)... ... June 23, 2017 , ... By scoring 100% for fiscal ... four-star rating from premier online charity evaluator, Charity Navigator, validating ANRF's work as a ... all charities reviewed by Charity Navigator and earns ANRF a spot on their “ ...
(Date:6/23/2017)... ... June 23, 2017 , ... Military Connection ... denied entry to the JFK Virgin Atlantic lounge. , Bensko is no stranger ... six years ago, Bensko dedicated her life to supporting our wounded veterans. A world-class ...
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... ... Breast Cancer Conference from Sept. 18 to 20. , The two-day conference is ... subtype with the goal of improving patients’ lives and eliminating racial breast cancer-related ...
Breaking Medicine News(10 mins):