A.P. Pharma announced that it has submitted a New Drug Application (NDA) to the FDA for its lead product, APF530 (granisetron), for the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting (CINV). The NDA submission is based on positive top-line results from a Phase 3 study where APF530 was shown to be equally as effective as Aloxi (palonosetron) in the prevention of both acute onset and delayed onset CINV.
APF530 contains the 5-HT3 antagonist, granisetron, formulated in A.P. Pharma’s proprietary Biochronomer™ drug delivery system, which allows therapeutic drug levels to be maintained for five days with a single subcutaneous injection.
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