IntelGenx to file NDA amendment in first quarter

IntelGenx Technologies (TSX-V:IGX) has met with the FDA to discuss a complete response letter received in February about its new drug application for its antidepressant CPI-300 and expects to file an amendment to the NDA in the first quarter of 2011.

CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL.  The two main issues which need to be addressed in order to obtain approval are the qualification of a commercial manufacturing site and the food effect, which was observed both in CPI-300 and the reference product in the food effect study submitted as part of the NDA.

“The required stability testing of the CPI-300 manufactured at our new CMO has already commenced, and we are diligently working towards resolving the food effect issue noted by FDA,” CEO Dr. Horst Zerbe said in a statement.  “Our meeting with FDA confirms that we are on track to complete the steps necessary to support the NDA amendment and obtain product approval.”