Avanir Pharmaceuticals, Inc., a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need, has received the United States Patent and Trademark Office (USPTO) allowance on a new patent that covers Avanir's product Nuedexta, further expanding the intellectual property portfolio for the company's lead commercial asset.
This asset is a dual sigma-1 and NMDA receptor modulator that is approved for the treatment of pseudobulbar affect (PBA), and is in clinical development for central neuropathic pain in patients with multiple sclerosis and agitation in patients with Alzheimer's disease.
US Patent application number 13/415,067, 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. The new patent will expire on July 17, 2023.
In addition to this newly allowed patent, 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.
“This newly allowed patent is a valuable addition to our intellectual property portfolio,” said Greg Flesher, senior vice president and chief business officer at Avanir Pharmaceuticals. “This additional layer of intellectual property protects our growing PBA business in the United States while we continue to explore additional clinical uses for Nuedexta.”
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 signalling, 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 Lou Gehrig's disease (ALS), multiple sclerosis (MS), Parkinson's disease, stroke, traumatic brain injury (TBI), and Alzheimer's disease.
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 underlying emotional state.