Avanir Pharmaceuticals Announces European Approval of NUEDEXTA
, /PRNewswire/ -- (NASDAQ: AVNR) today announced that the European Commission has approved NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) in the European Union for the treatment of pseudobulbar affect (PBA), irrespective of underlying neurologic disease or injury.
"The approval of NUEDEXTA by the European Commission is a major breakthrough for people with PBA who, until now, have had no EMA approved medications indicated to treat this debilitating disorder," said , MD, chief scientific officer at Avanir. "NUEDEXTA addresses a genuine unmet patient need and demonstrates Avanir's commitment to bringing innovative treatments to people in and throughout the world."
PBA is a neurologic condition characterized by outbursts of uncontrollable crying or laughing 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 disruption in occupational and social function, often leading to social isolation. PBA occurs secondary to a variety of neurologic conditions such as traumatic brain injury, multiple sclerosis, amyotrophic lateral sclerosis ( disease), 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.
NUEDEXTA is an innovative combination of two well-characterized components; dextromethorphan hydrobromide, the ingredient active in the central nervous system, and quinidine sulfate, 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 approved in the U.S. for the treatment of PBA with a 20/10 mg dose strength. NUEDEXTA is now approved in all 27 member states of the European Union, plus and , for the treatment of PBA with a 20/10 mg and 30/10 mg dose strength.
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 evaluated 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.
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 and other countries.
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SOURCE Avanir Pharmaceuticals, Inc.