Nuedexta
Generic name: dextromethorphan and quinidine
Treatment for: Pseudobulbar Affect
FDA Informs Avanir of Revised Neurodex NDA Action Date
SAN DIEGO, June 19, 2006 - AVANIR Pharmaceuticals announced that it was advised today in a teleconference with the U.S. Food and Drug Administration (FDA), that the Agency will extend the review period by 90 days for the Neurodex new drug application (NDA) for Involuntary Emotional Expression Disorder (IEED). The new PDUFA date will be October 30, 2006. The additional time is needed to allow the FDA sufficient time to review the final study report of the recently completed thorough QT study. For additional information on the results of the QT study, please refer to the Company's press release issued on June 5, 2006.
"While we are disappointed that there will be a delay in hearing about the status of the Neurodex NDA, we believe the QT data provides added support to the safety profile of the drug," said Eric K. Brandt, President and Chief Executive Officer of AVANIR. "AVANIR has had a strong and collaborative relationship with the FDA, and we will continue to work to achieve the approval of Neurodex for IEED."
About Neurodex
Neurodex is a combination of two well-characterized compounds, the active ingredient dextromethorphan, and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. The first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways, through presynaptic inhibition of glutamate release via sigma-1 receptor agonist activity, and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity.
Source: AVANIR Pharmaceuticals
Posted: June 2006
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Nuedexta (dextromethorphan and quinidine) FDA Approval History
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