IntelGenx Corp. OTC.BB:IGXT - News) ("IntelGenx") today announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration ("FDA") regarding the Company's New Drug Application ("NDA") for its antidepressant CPI-300, which it developed with Cary Pharmaceuticals ("Cary Pharma"). CPI-300 is a novel, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL®. IntelGenx's development partner, Cary Pharma, serves as the NDA applicant for CPI-300.
The FDA issues Complete Response Letters to request additional information needed to complete the review of an NDA. As expected, the Complete Response Letter lists two main issues which need to be addressed in order to obtain approval, namely 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. Other than these two issues, which management believes can be effectively addressed, the FDA found no other notable deficiencies in the NDA.
"This Complete Response Letter gives us the clarity and confidence necessary to complete the development of CPI-300 and push towards the submission of an NDA amendment in the second half of this year," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "There were no surprises for us in the letter, as we had alerted FDA to the manufacturing issue ourselves and have been aware of the agency's sensitivity towards the food effect which is being observed in all bupropion extended-release products. That has allowed us to proactively manage the situation and stay on course for a possible late 2010 FDA approval."
As noted in a January 11, 2010 press release, IntelGenx notified the FDA of its intent to switch its contract manufacturing organization ("CMO"). The Company has already identified a new CMO and has begun the process of generating the data required to support an amendment to its NDA.
In its Complete Response Letter FDA also notes of a possible food affect with CPI-300. The Company believes this issue can be overcome through a label adjustment and a thorough post-approval educational effort. In the coming weeks the Company will make a request for a meeting with FDA to clarify the required steps necessary to obtain product approval. The Company is confident that the activities required to support the NDA amendment can be completed in time for a submission in the second half of 2010.
IntelGenx and Cary Pharma entered into a Collaborative Agreement in November 2007 to jointly develop and commercialize CPI-300 using IntelGenx's proprietary oral delivery technology.
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