The European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) from Avanir Pharmaceuticals, Inc., for Nuedexta (dextromethorphan HBr and quinidine sulfate) for the treatment of pseudobulbar affect (PBA). Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review.

Nuedexta was approved by the US Food and Drug Administration (FDA) in October 2010 for the treatment of PBA, a neurologic condition which is characterized by frequent outbursts of involuntary crying or laughing.

The MAA is based on comprehensive clinical data from Avanir's controlled phase III studies of Nuedexta in patients with PBA, plus data from the company's longer-term safety studies. The MAA acceptance triggers the initiation of EMA's scientific assessment and opinion review period.

Additionally the company received notification from the EMA that the Name Review Group and the Committee for Medicinal Products for Human Use had no objections to the proposed use of the trade name Nuedexta.

Patients suffering from existing neurological disease or brain injury may also suffer the added burden of pseudobulbar affect, or 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 patient's underlying emotional state. PBA outbursts result from a "short circuit" in the brain caused by another neurologic condition--such as multiple sclerosis, amyotrophic lateral sclerosis (or Lou Gehrig's disease), stroke, traumatic brain injury, Parkinson's disease or dementias including Alzheimer's.

Nuedexta is the first and only FDA-approved treatment for pseudobulbar affect (PBA). It 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 it exerts therapeutic effects in patients with PBA is unknown.

Nuedexta can interact with other medications causing significant changes in blood levels of those medications and/or Nuedexta. Nuedexta is contraindicated in patients receiving drugs that both prolong QT interval and are metabolized by CYP2D6 (e.g., thioridazine and pimozide) and should not be used concomitantly with other drugs containing quinidine, quinine, or mefloquine. Nuedexta is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or in patients who have taken MAOIs within the preceding 14 days and also in patients with a known hypersensitivity to its components.