WASHINGTON (dpa-AFX) - Biopharmaceutical company Avanir Pharmaceuticals Inc (AVNR) Thursday stated that the European Medicines Agency, or EMA, has accepted the filing of the Marketing Authorization Application or MAA, for NUEDEXTA for the treatment of pseudobulbar affect or PBA.
The company stated that 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 company further noted that the Marketing Authorization Application 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.
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