IntelGenx received a complete response letter from the FDA regarding the NDA for its antidepressant CPI-300. The agency raised two issues: 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.
CPI-300 is a high-strength version of bupropion HCl, the active ingredient in GlaxoSmithKline’s Wellbutrin XL®. It is being developed with Cary Pharma.
“This complete response letter gives us the clarity and confidence necessary to complete the development of CPI-300 and push toward the submission of an NDA amendment in the second half of this year,” says Horst G. Zerbe, Ph.D., president and CEO. “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 toward 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.”
On January 11, IntelGenx notified the FDA of its intent to switch its CMO from PharmPro to Pillar5 Pharma. IntelGenx has begun generating data required to support an amendment to its NDA.
PharmPro sold its Aurora, IL, manufacturing facility and assets to URL Pharma, and the new owners decided not to operate the facility in Aurora as a CMO. IntelGenx thus engaged Pillar5 Pharma, which acquired a manufacturing site in Arnprior, Ontario, from Keata Pharma in December 2009.
During an end of Phase II meeting with the FDA, the agency reviewed results from a food-effect study and said that it would accept a labeling that the product may be taken without regard to food. IntelGenx believes that this issue, raised again in the complete response letter, 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 firm 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 an agreement in November 2007 to jointly develop and commercialize CPI-300 using IntelGenx's oral-delivery technology. IntelGenx uses its multiple-layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract.
The company has also developed delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx's R&D pipeline includes products for the treatment of pain, hypertension, osteoarthritis, and depressive disorders.