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news.IntelGenx has recently met with the FDA to discuss its response to the complete response letter received in February from the FDA regarding the company's new drug application for its antidepressant CPI-300 and to clarify the required steps necessary to obtain product approval.
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IntelGenx said that 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.
FDA has agreed to the IntelGenx’s proposed clinical plan to address the previously observed food effect and to demonstrate bioequivalency of product manufactured at the new manufacturing site.
IntelGenx expects to file the amendment to the NDA in the first quarter of 2011, based on FDA’s recommendations regarding the stability data required to support the new manufacturing site.
Horst Zerbe, president and CEO of IntelGenx, said: “Our meeting with FDA was very constructive and we gained some clarity on the regulatory pathway for approval of CPI-300.
“The required stability testing of the CPI-300 manufactured at our new CMO has already started, and we are diligently working towards resolving the food effect issue noted by FDA.
“Our meeting with FDA confirms that we are on track to complete the steps necessary to support the NDA amendment and obtain product approval.”