A.P. Pharma, Inc. (OTCBB: APPA), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s resubmission of its New Drug Application (NDA) for APF530. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of March 27, 2013. APF530 is a long-acting formulation of granisetron and is being developed for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV).
"The acceptance of our New Drug Application for APF530 represents an important step towards providing physicians and patients with a potential new long-acting therapeutic agent to combat the debilitating side effects of nausea and vomiting associated with many chemotherapy treatments," said John B. Whelan, A.P. Pharma’s president and chief executive officer. “We will continue working with the FDA as it reviews our NDA submission, recognizing the important role APF530 could play in reducing chemotherapy treatment side effects for cancer patients.”
A.P. Pharma’s NDA for APF530, which was resubmitted to the FDA on September 27, 2012, seeks approval to market and sell APF530 in the United States for the prevention of acute- and delayed-onset CINV. 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.
About CINVPrevention and control of nausea and vomiting, or emesis, are very important in the treatment of cancer patients. The majority of patients receiving chemotherapy will experience some degree of emesis if not prevented with an antiemetic, typically administered just prior to chemotherapy. Chemotherapy treatments can be classified as moderately emetogenic, meaning that 30% to 90% of patients experience CINV, or highly emetogenic, meaning that more than 90% of patients experience CINV, if they do not receive an antiemetic. Acute-onset CINV occurs within the first 24 hours following chemotherapy treatment. Delayed-onset CINV occurs more than 24 hours after treatment and may persist for several days. Prevention of CINV is important because the distress caused by CINV can severely disrupt patient quality of life and can lead some patients to delay or discontinue chemotherapy.