CPI-300 is a high strength of Bupropion Hydrochloride (HCl), the active ingredient in Wellbutrin XL.
The company’s new submission addresses the two main issues identified by the FDA – 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.
In accordance with its guidelines, the FDA is expected to classify the complete response as a Class 1 or Class 2 resubmission, and also provide the company with an updated prescription drug user fee act (PDUFA) target action date within weeks.
IntelGenx president and CEO Horst Zerbe said they are confident that they have addressed the requests that were outlined by the FDA in its CRL.
"We are actively discussing commercialization rights and strategies for CPI-300 with a number of interested potential partners. Furthermore we are very pleased to have the Biovail litigation behind us, so that CPI-300 can immediately be marketed upon approval," Zerbe said.