In the CRL, the FDA noted that during an inspection of the manufacturing facility of an API (active pharmaceutical ingredient) supplier that concluded last week, inspection deficiencies were found. Satisfactory resolution of deficiencies noted by the field investigator is required before the NDA for PA8140/PA32540 (aspirin and omeprazole) delayed release tablets may be approved.
Pozen said it believes that these manufacturing facility items can be addressed and will be working with the manufacturer to respond to the FDA as soon as possible.
“Although we were hopeful for a first cycle approval, we believe that the issues raised during the inspection can be remedied to the satisfaction of the FDA. The timing of the inspection of this facility was unfortunate as the final inspection report was only issued today. Because it occurred so close to our PDUFA date, there was no opportunity to address the issues raised,” said John R. Plachetka, Chairman, President and CEO.
There were no clinical or safety deficiencies noted with respect to either PA8140 or PA32540 and no other deficiencies were noted in the CRL. Final agreement on the draft product labeling is also pending. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core.
“We don’t want to speculate on the timing of the resubmission of the NDA, or the timeline for eventual FDA action on that resubmission until we have had a chance to talk again with all the concerned parties, including the FDA. We will move as quickly as we can to resolve any outstanding issues. We hope to be able to provide more information about timing during our earnings call on May 8