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First Treatment for Pseudobulbar Affect Approved

11/1/2010

Nuedexta™ (dextromethorphan hydrobromide and quinidine sulfate) has been approved in capsule form by the Food and Drug Administration (FDA) as the first line of treatment for uncontrolled laughing or crying, medically known as pseudobulbar affect (PBA), Avanir Pharmaceuticals Inc. has announced.

An oral therapy, Nuedexta has shown in clinical trials to significantly reduce PBA episodes in people with MS, ALS and other disorders. PBA is a neurologic condition characterized by involuntary, sudden and frequent episodes of crying or laughing which are not proportional to the person’s true emotional state.

PBA has been recognized as a symptom of MS. It is estimated that approximately 10 percent of the people with MS experience PBA. Avenir is reporting that one million Americans are moderately or severely affected with PBA.

Dr. Erik Pioro, Cleveland Clinic, Director of ALS Section, also a researcher in the Nuedexta clinical trials, said: “PBA is a disabling neurologic condition commonly found in patients with underlying neurologic diseases or injuries. These patients frequently experience embarrassment due to their unpredictable emotional outbursts, leading to disruption of their interpersonal relationships and social isolation. As a physician who has cared for many patients with PBA, I am pleased that there is now a safe and effective treatment option for PBA that may help these patients regain more control over their daily lives and live with dignity.”

For more information go to www.nuedexta.com.

 



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