CHMP recommends approval of Nuedexta (Avanir Pharma) for Pseudo Bulbar Affect
The EMA's CHMP has adopted a positive opinion for Nuedexta (dextromethorphan hydrobromide and quinidine sulphate), from Avanir Pharma, recommending it be approved for the treatment of Pseudo Bulbar Affect (PBA), irrespective of neurologic cause. In addition, the CHMP also recommended approval of two dose strengths; 20/10 mg and 30/10 mg capsules.
The drug has been tested in the Phase III STAR trial which investigated 2 doses of Nuedexta compared to placebo in PBA in patients with underlying Multiple Sclerosis and ALS. Over 12 weeks the drug met primary endpoints and reduced episodes by 47.2% (20mg) and 47.8% (10mg). Lower doses are intended to avoid risk of arrhythmias and had no negative effect on efficacy.
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