A.P. Pharma announced that the FDA has accepted for review the New Drug Application (NDA) submitted for APF530 for the treatment of chemotherapy-induced nausea and vomiting (CINV). APF530 is being developed for the prevention of both acute and delayed onset CINV. The NDA is based on results from a Phase 3, multicenter, randomized trial in 1,395 cancer patients that showed APF530 to be equally as effective as Aloxi (palonosetron, from Eisai)
APF530 is a long-acting formulation of granisetron, a 5-HT3 antagonist, that utilizes 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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