ALISO VIEJO, Calif.
Aug. 3, 2012
Avanir Pharmaceuticals, Inc.
(NASDAQ: AVNR) announced today that an additional patent covering Avanir's NUEDEXTA® (dextromethorphan HBr and quinidine sulfate) product has been listed in the U.S. Food and Drug Administration's (FDA) Orange Book.
The Orange Book listing requires an Abbreviated New Drug Application (ANDA) applicant, seeking FDA approval for a generic version of NUEDEXTA prior to expiration of the patent, to notify Avanir of its ANDA filing before it can obtain FDA approval.
The additional patent, U.S. Patent number 8,227,484, entitled "Pharmaceutical Compositions Comprising Dextromethorphan and Quinidine for the Treatment of Neurological Disorders," claims methods for treating pseudobulbar affect or emotional lability using low-dose quinidine formulations of NUEDEXTA. This additional patent, whose allowance was previously announced by Avanir on
July 2, 2012
, issued on
Avanir Pharmaceuticals now has three patents listed in the FDA Orange Book:
- Patent number: RE38,115 which expires in 2016
- Patent number: 8,227,484 which expires in 2023
- Patent number: 7,659,282 which expires in 2026
In addition to these listed patents, the company has exclusive worldwide rights to a family of patents and patent applications that claim methods of treating various neurologic and psychiatric conditions using low-dose quinidine formulations of NUEDEXTA.
About Pseudobulbar Affect
People with pseudobulbar affect (PBA) have sudden outbursts of involuntary crying or laughing, even though there may not be anything particularly sad or funny to trigger those emotions. Many people who suffer from PBA describe their episodes as uncontrollable, exaggerated, or different from their true feelings. PBA may occur when certain neurologic diseases or injury damage the areas of the brain that control normal expression of emotion. This damage can disrupt brain signaling, causing a "short circuit" and triggering episodes of involuntary crying or laughing. PBA can occur in people diagnosed with a variety of otherwise unrelated neurologic conditions such as
's disease (ALS), multiple sclerosis (MS), Parkinson's disease, stroke, traumatic brain injury (TBI), and Alzheimer's disease. For more information about PBA, please visit
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.