ALISO VIEJO, Calif., May 30, 2014 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that data related to the prevalence and treatment of pseudobulbar affect (PBA), a distressing neurological condition characterized by uncontrollable laughing or crying, will be presented at the following conferences in June.
Joint Congress of European Neurology (EFNS-ENS), May 31 - June 3, 2014, Istanbul
-- Burden of pseudobulbar affect (PBA) symptoms in veterans with traumatic brain injury (TBI) -- Abstract Number: A-635-0018-01071 -- Poster Session: Neuro-epidemiology; Neurorehabilitation -- Time: June 1 at 12:30 p.m. EEST -- Dextromethorphan/Quinidine (DMQ) treatment significantly increased percentage of days free of pseudobulbar affect (PBA) episodes in a phase 3, randomized, placebo-controlled trial -- Abstract Number: A-635-0005-02074 -- Poster Session: Clinical neurophysiology -- Time: June 1 at 12:30 p.m. EEST -- Dextromethorphan/Quinidine for treatment of pseudobulbar affect: analysis of treatment-related adverse events -- Abstract Number: A-635-0005-02075 -- Poster Session: Clinical neurophysiology -- Time: June 1 at 12:30 p.m. EEST -- Time to sustained remission of pseudobulbar affect (PBA) episodes after treatment with dextromethorphan and quinidine -- Abstract Number: A-635-0005-02618 -- Poster Session: Clinical neurophysiology -- Time: June 1 at 12:30 p.m. EEST
International Society for Pharmacoeconomics and Outcomes Research (ISPOR), May 31 - June, 4, 2014, Montreal
-- Screening for PBA Symptoms Using a Single Question vs. a 7 Question Measure and Assessment of the Association of PBA Symptoms with HRQOL Burden -- Abstract Number: PND45 -- Session: Research Posters Session I -- Time: June 2 at 1:15 p.m. EDT
PBA is a neurologic condition characterized by uncontrollable, disruptive laughing and/or crying outbursts that are often contrary or exaggerated to the patient's inner mood state. As a result, many of those afflicted with PBA show significant impairment on standard measures of health status, and impairments in occupational and social function, often leading to social isolation. PBA occurs secondary to a variety of neurologic conditions such as traumatic brain injury (TBI), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, stroke and Alzheimer's disease. When these disorders damage areas of the brain that regulate normal emotional expression, they can lead to uncontrollable, disruptive episodes of crying or laughing. For more information about PBA, please visit www.pbafacts.com
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 and certain other medicines can interact, causing serious side effects. If you take certain drugs or have certain heart problems, NUEDEXTA may not be right for you.
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.
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.
These are not all the risks from use of NUEDEXTA. Please refer to full Prescribing Information at 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® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries.
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