REDWOOD CITY, Calif. The Food and Drug Administration raised a number of concerns that it said precluded the approval of a drug made by A.P. Pharma for preventing sickness in patients taking chemotherapy, A.P. said Friday.
A.P. has been trying to win approval for APF530, for preventing acute and delayed-onset chemotherapy-induced nausea and vomiting, but the FDA issued the company a complete response letter. The FDA issues complete response letters when the review of a file is completed, but questions remain that don’t allow it to grant final approval.
Specifically, the FDA cited potential problems with the two-syringe dosing system of the drug and potential transfer of material from one syringe to the other. There were also problems with A.P. Pharma’s manufacturing of the drug, according to the letter, including unspecified “deficiencies” found during an FDA inspection of the company’s factories, and the sterilization methods used. The agency didn’t ask for additional efficacy studies, but did ask for re-presentation and re-analysis of existing phase-3 clinical trial data and additional studies related to bioavailability and metabolism.