Avanir Pharmaceuticals announced that the FDA has approved Nuedexta (dextromethorphan hydrobromide and quinidine sulfate capsules) for the treatment of pseudobulbar affect (PBA). This approval was based on studies conducted in patients with amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS) which showed that patients treated with Nuedexta experienced significantly lower laughing and crying episodes, the primary outcome measure, as compared to placebo. The secondary outcome measure, the Center for Neurologic Studies Liability Scale (CNS-LS), demonstrated a significantly greater mean decrease in CNS-LS score from baseline for the Nuedexta arm compared to placebo.
Nuedexta consists of an uncompetitive NMDA receptor antagonist/sigma-1 agonist plus a CYP450 2D6 inhibitor. However, the exact mechanism by which Nuedexta exerts therapeutic effects in patients with PBA is unknown.
Nuedexta is expected to be available during the first quarter of 2011.
For more information call (949) 389-6700 or visit www.nuedexta.com.