Avanir Neurodex NDA Delayed By FDA Request For Additional Analyses

Avanir will meet with FDA "within the next few weeks" to discuss delays in its NDA for Neurodex for treatment of pseudobulbar affect, the firm says.

"The agency requested that the company provide an expansion of certain summary analyses in its application to better support the new electronic data submission guidelines," Avanir said Sept. 22.

The firm emphasized that it does not expect the delay to be significant.

According to Avanir, the rolling NDA submission for Neurodex (dextromethorphan/quinidine) was completed June 29, with a request for a priority review (¹ Pharmaceutical Approvals Monthly July 2005, In Brief).

However, the firm announced in late August that FDA had determined Aug. 10 to be the filing date "due to supplemental data provided by the [firm] on that date."

Upon submission of the additional analyses requested by the agency, the company expects FDA to reset the NDA receipt date again, Avanir said.

The agency currently is planning a guidance on the submission of analysis datasets in electronic filings of clinical data.

Electronic filing issues have been the cause of delays for several approval applications, including Teva's Agilect (² Pharmaceutical Approvals Monthly August 2005, In Brief) and Pfizer's indiplon (³ Pharmaceutical Approvals Monthly June 2005, In Brief).

Avanir has estimated a $500 mil. market opportunity for PBA - a symptom complex secondary to multiple neurological conditions including Alzheimer's, Parkinson's, multiple sclerosis and stroke, characterized by emotional lability (⁴ Pharmaceutical Approvals Monthly September 2004, p. 13).

Nevertheless, the firm believes Neurodex has a larger opportunity for diabetic neuropathy; Phase III studies in that indication are ongoing.

[Editors' note: A version of this story first appeared in ⁵ "The Pink Sheet" DAILY on Sept. 22. Visit our website, www.ThePinkSheetDAILY.com, to sign up for a free trial.]