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news.FDA has issued Complete Response Letter to IntelGenx for it's New Drug Application (NDA) of the antidepressant CPI-300, which the company developed with Cary Pharmaceuticals (Cary Pharma).
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CPI-300 is a new, high strength of Bupropion HCl, the active ingredient in Wellbutrin XL(R). 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. It 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.
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.
The company said that in the coming weeks it 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.
Announced earlier, the company had notified the FDA of its intent to switch its contract manufacturing organisation (CMO). Accordingly, it has identified a new CMO and has begun the process of generating the data required to support an amendment to its NDA.
IntelGenx and Cary Pharma entered into a collaborative agreement in November 2007, to jointly develop and commercialise CPI-300 using IntelGenx’s proprietary oral delivery technology.
Horst Zerbe, president and CEO of IntelGenx, said: “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.
“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.”