AP Pharma, Inc, a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for APF530 for the potential treatment of chemotherapy-induced nausea and vomiting (CINV). APF530 is a long-acting formulation of granisetron that utilizes the company's proprietary Biochronomer drug delivery system. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has issued an action date of March 18, 2010.

"The acceptance of the APF530 NDA represents another important step towards providing physicians and patients with a potential new long-acting therapeutic agent to combat chemotherapy-induced nausea and vomiting," said Ronald J Prentki, AP Pharma's president and chief executive officer. "Our team recognizes the important role APF530 could play in cancer care, and we are dedicated to working with the FDA as it reviews our NDA submission." The NDA was submitted under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, whereby the Company can rely upon the FDA's prior safety and efficacy findings for APF530's active ingredient, granisetron.

AP Pharma's lead product candidate, APF530, is being developed for the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting (CINV).

Prevention and control of nausea and vomiting, or emesis, are very important in the treatment of cancer patients.

AP Pharma is a specialty pharmaceutical company developing products using its proprietary Biochronomer polymer-based drug delivery technology.