Navigation Links
Avanir Pharmaceuticals Announces Paragraph IV ANDA Filing for NUEDEXTA
Date:7/1/2011

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 contraindica
'/>"/>

SOURCE Avanir Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

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:8/27/2014)... Research and Markets  has announced the ... 2014" report to their offering. ... professional and in-depth study on the current state of ... provides a basic overview of the industry including definitions, ... market analysis is provided for the international markets including ...
(Date:8/27/2014)... Aug. 27, 2014   Los Angeles orthodontics ... Aura to patients who want to make their treatment ... at the OrthoSpaceship, all patients have a powerful tool ... system can be used by most patients with all ... progress by using the AcceleDent® Aura system for a ...
(Date:8/27/2014)... 27, 2014 ISPE , the International ... released a preview of its Drug Shortages Prevention ... drug shortages and maintain a robust and reliable supply ... Plan, a first for the industry, was developed by ... and describes how industry can best prevent drug shortages ...
Breaking Medicine Technology:Global Pulse Oximeter Industry Report 2014 2Los Angeles Orthodontist, Dr. Isaac Hakim, is Now Offering AcceleDent Aura 2ISPE Releases First Look at its Plan to Prevent Drug Shortages 2ISPE Releases First Look at its Plan to Prevent Drug Shortages 3ISPE Releases First Look at its Plan to Prevent Drug Shortages 4
(Date:8/27/2014)... 27, 2014 Shawna's new book, released ... about Seed Digging, which a brand-new technique she created. ... yet works to bring permanent healing quickly. , According ... mental health disorders cured on a daily basis. It ... minds and find incredible inner peace with only a ...
(Date:8/27/2014)... Recently, iFitDress.com, a professional company of women’s dresses ... romantic bridal gowns . To top it all ... to 66 percent off) when buying the company’s new ... been updated with these new items. All its online ... all clients can gain an enjoyable shopping experience on ...
(Date:8/27/2014)... August 27, 2014 Seventy-three members of ... (SoP) celebrated the beginning of their careers as healthcare ... August 23. Students entering a four-year PharmD program traditionally ... ?to welcome them into the profession as colleagues dedicated ... held at the Garrison Theater in Claremont, Calif., KGI ...
(Date:8/27/2014)... Clara, CA (PRWEB) August 27, 2014 ... Mexico vs. Chile tickets at Levi’s Stadium in Santa ... located in Santa Clara, California just opened in July and ... 6 when Mexico takes on Chile. These are two of ... at the 2014 World Cup and will look to continue ...
(Date:8/27/2014)... Dr. Stewart Shofner and Dr. Kevin ... suffering from impaired vision. Some of the most common ... . Recently, Dr. Shofner has noticed a significant increase ... and also online. To help patients understand the facts, ... , 1)    Myth: People with perfect vision won’t develop glaucoma. ...
Breaking Medicine News(10 mins):Health News:Shawna Burns, Counselor, Releases Debut Book, "Seed Digging," to Improve Lives of Children and Adults with Addictions and Mental Health Disorders 2Health News:Promotion For Romantic Bridal Gowns Launched By Professional Company iFitDress.com 2Health News:Founding Class of the KGI School of Pharmacy Formally Welcomed into the Profession at a Traditional White Coat Ceremony 2Health News:Mexico vs. Chile Tickets at Levi’s Stadium: Ticket Down Cuts Ticket Prices for Inaugural Soccer Match between Chile and Mexico in Santa Clara 2Health News:Mexico vs. Chile Tickets at Levi’s Stadium: Ticket Down Cuts Ticket Prices for Inaugural Soccer Match between Chile and Mexico in Santa Clara 3Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 2Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 3Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 4
... been the nation of high discussion during the G8 Summit. ... WHO started its campaign “3 by 5” antiretroviral campaign prior ... on rich countries to provide more funds and importance to ... high profile of Africa’s dire problems overshadow some of the ...
... combat HIV infection among its cadres, the Border Security ... border outpost along West Bengal's international boundary. // ... initiative launched in collaboration with the state AIDS control ... BSF troopers. ,"We are setting up these condom ...
... at the University of Texas Medical Branch at Galveston (UTMB) ... blood that cause the “mad cow disease” in people. According ... the prions that are there in the blood causing the ... online version of Nature Medicine. The findings from the study ...
... Scientists from Indiana University had found that doing household ... the car etc could prevent hypertension and conditions of ... that regardless of intensity, four hours of accumulated daily ... participants' blood pressure by a category -- from hypertensive ...
... is an endocrine disorder characterized by nervous irritability, ... and pelvic congestion. ,For the first time, ... and dosing regimen has been found effective in ... most severe form of premenstrual syndrome. ...
... system has the remarkable ability to discriminate between self ... the immune system, the human body would have lost ... death. // ,The immune system produces certain ... cancer cells, effectively labeling them as "bad" so that ...
Cached Medicine News:Health News:Africa Is Not The Only Continent Struggling Against AIDS 2Health News:Free Condom Counters For Border Security Force Cadres 2Health News:They Call It PMS Because Mad Cow Disease Was Already Taken 2Health News:Fighting against disease as easy as eating eggs 2
... stylish Thalia eyeglasses eyewear collection ... appeal of the renowned Latin ... of eyeglasses eyewear is ultra-sleek, ... ophthalmic styles that include decorative ...
... a remarkable sunwear collection, affectionately known as ... of the benefits of the Titan Minimal ... top quality sun lenses that offer 100% ... They provide the most comfortable, lightweight sun ...
... The name Silhouette stands for ... It all began in 1964 with ... five and a novel, pioneering approach: ... a simple implement to improve faulty ...
... something that almost all retailers must address ... with VALUE - not just in price ... Research shows that National is among the ... ,National offers an exciting collection of contemporary ...
Medicine Products: