ALISO VIEJO, Calif., Nov. 17, 2011 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR ) announced today that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) 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 U.S. Food and Drug Administration 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 3 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. PBA can have a debilitating impa