ALISO VIEJO, CA, USA I April 26, 2013 I Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate), recommending NUEDEXTA be approved for the treatment of pseudobulbar affect (PBA), irrespective of neurologic cause. In addition, the CHMP also recommended approval of two dose strengths of NUEDEXTA; 20/10 mg and 30/10 mg capsules.
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“The positive opinion from CHMP and recommendation for a broad PBA label for NUEDEXTA is a key step in the regulatory process toward having the first and only evidence-based treatment for PBA approved in the European Union,” said Dr. Joao Siffert, chief scientific officer of Avanir. “We will continue to work with the European Medicines Agency and the European Commission toward the marketing authorization so that patients suffering from PBA have ready access to NUEDEXTA in Europe.”
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 (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.
“PBA causes substantial medical and social burden,” said Professor Kevin Talbot, director of the Oxford Motor Neuron Disease Care & Research Center. “Appropriate management of this debilitating condition can have meaningful clinical benefits for patients. Once available in Europe, NUEDEXTA will offer an important therapeutic option to effectively manage PBA.”
The European Commission, which has the authority to approve medicines for use in the European Union, generally follows the recommendations of the CHMP and typically renders a final decision within three months of the CHMP opinion. If the CHMP recommendation is formally adopted by the European Commission, NUEDEXTA would be approved for marketing in all 27 member states of the European Union plus Iceland and Norway.
For further details about the CHMP opinion, please visit the EMA website.
About NUEDEXTA
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 in the 20/10 mg dose strength.
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 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.
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.
SOURCE: Avanir
