Friday, Avanir Pharmaceuticals, Inc. (AVNR)said that the U.S. Food and Drug Administration) has approved Nuedexta as the first treatment for pseudobulbar affect.
Nuedexta, dextromethorphan hydrobromide and quinidine sulfate,
is indicated for the treatment of pseudobulbar affect or PBA.
The company said that 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.
Keith Katkin, chief executive officer, said, "The FDA approval of NUEDEXTA marks an important milestone for people living with PBA, an under-recognized and debilitating neurologic condition. The approval of NUEDEXTA also marks AVANIR's transition toward becoming a commercial enterprise, ready to support the successful launch of the first FDA-approved treatment for PBA. We expect that NUEDEXTA will be available by prescription during the first quarter of 2011."
Nuedexta is a first-in-class medication that acts on sigma-1 and NMDA receptors in the brain, although the exact mechanism by which it exerts therapeutic effects in patients with PBA is unknown.
The company said that studies to support the effectiveness of the drug were performed in patients with amyotrophic lateral sclerosis and multiple sclerosis. 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.
The primary outcome measure, laughing and crying episodes, was significantly lower in the Nuedexta arm compared with placebo. The secondary outcome measure, the Center for Neurologic Studies Lability Scale, showed a greater mean decrease in CNS-LS score from baseline for the Nuedexta arm compared to placebo.
For comments and feedback: editorial@rttnews.com