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Avanir To File Neurodex NDA For Pseudobulbar Affect By End Of 2004

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Avanir could see action on its upcoming Neurodex NDA for the treatment of pseudobulbar affect by mid-2005; the firm plans to submit the application by the end of the year and will request priority review.

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Avanir is requesting a priority review for use of its anti-excitatory therapy Neurodex (dextromethorphan/quinidine) in the treatment of pseudobulbar affect (PBA). The firm completed a rolling submission of the NDA for the neurological disorder June 29. A priority review designation would make approval possible before year end. Avanir previously estimated the U.S. PBA market at $500 mil.; the firm also indicated it planned to have 70 reps in place for launch (1Pharmaceutical Approvals Monthly September 2004, p. 13). PBA is a symptom complex secondary to multiple neurological conditions including Alzheimer's, Parkinson's, multiple sclerosis and stroke...

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