Monday, specialty pharmaceutical company A.P. Pharma, Inc. (APPA) said that the U.S. Food and Drug Administration, or FDA, has accepted for review the New Drug Application, or NDA, of its product candidate for the treatment of chemotherapy-induced nausea and vomiting, or emesis.
The company noted that, based on the Prescription Drug User Fee Act, the FDA has issued an action date of March 18, 2010.
APF530, a formulation of granisetron, is being developed for the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting, or CINV, and utilizes the company's proprietary Biochronomer drug delivery system.
In September 2008, A.P. Pharma reported positive top-line results from its multi-center, randomized Phase 3 study that enrolled 1,395 cancer patients. APF530 was shown to be equally as effective or statistically non-inferior to palonosetron in the prevention of both acute onset and delayed onset CINV.
The company said that 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.
APPA closed Friday's trading at $0.88 on the Nasdaq.
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