Avanir submits expanded application for Neurodex

The company says its new application provides additional clinical data showing that Neurodex, a combination of dextromethorphan and quinidine, is safe and effective in reducing the frequency and severity of sudden and uncontrollable crying and/or laughing episodes that occur as a consequence of neurological disease or injury.

Along with its application Avanir has also requested priority review status, meaning approval could be granted within six months. Should standard review status be granted, a review time of around ten months would apply.

Eric Brandt, president of Avanir was keen to point out that there was nothing odd about the FDA’s desire for additional data. “While the FDA’s request was limited to reorganization and expanded discussions of existing data within the electronic document, we took the time to include additional safety data rather than providing it as a separate supplemental filing as originally planned. The additional safety data are consistent with the data previously submitted.”