AP Pharma’s APF530 contains the 5-HT3 antagonist, granisetron, formulated in the company’s proprietary Biochronomer drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection.
The FDA has expressed concerns relating to AP Pharma’s two-syringe administration system, including potential issues with the transfer of material from one syringe to the other syringe prior to patient administration, certain components used in the dosing system and the potential risk of improper administration of the drug product.
Additionally, FDA has completed inspections of the company’s several contract manufacturing facilities and identified certain deficiencies, further stating that satisfactory resolution of these deficiencies will be required for approval.
The FDA has asked the company to determine if terminal sterilization with gamma irradiation is a feasible approach to enhance the assurance of sterility, wheras AP Pharma has subsequently demonstrated that terminal sterilization is feasible. The FDA has requested the company change to terminal sterilization prior to approval.
The FDA has also sought clarification and revision of certain analytical specifications proposed in the company’s NDA and to perform two studies relating to bioavailability and metabolism.
The company said that it will be contacting the FDA to request an End-of-Review meeting to discuss the Complete Response Letter. AP Pharma is committed to expeditiously resolving the remaining issues required for FDA approval; however, based on the anticipated time needed to prepare a resubmission, the company does not anticipate the commercial launch of APF530 in 2010.