September 5, 2006

FDA Postpones Decision on Drug That May Improve Emotional Control in ALS

The Food and Drug Administration has advised Avanir Pharmaceuticals (www.avanir.com) that it will delay making a decision about approval of Neurodex for emotional lability (uncontrollable emotions) in amyotrophic lateral sclerosis (ALS) and other conditions until Oct. 30.

Neurodex is a combination of dextromethorphan hydrobromide and quinidine sulfate that appears to be more effective than either compound alone in reducing episodes of undesired emotional expression.