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Company Resubmits NDA for Chemo Nausea Drug
FDA review expected within 6 months (Sept. 28)
A.P. Pharma, Inc., based in Redwood City, Calif., announced on September 28 that it has resubmitted its new drug application (NDA) to the FDA for APF530 (granisetron) for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). The company expects a Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks, and FDA review within 6 months.
The majority of patients receiving chemotherapy will experience some degree of nausea and vomiting (emesis) if it is not prevented with an antiemetic, typically administered just prior to chemotherapy.
Chemotherapy treatments can be classified as moderately or highly emetogenic. With moderately emetogenic therapy, 30% to 90% of patients experience CINV if they do not receive an antiemetic. With highly emetogenic therapy, more than 90% of patients experience CINV.
Acute-onset CINV occurs within the first 24 hours after 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 a patient’s quality of life and can lead some patients to delay or discontinue chemotherapy.
APF530 contains the 5-HT3 antagonist granisetron, formulated in the company’s proprietary Biochronomer drug delivery system, which allows therapeutic drug levels to be maintained for 5 days with a single subcutaneous injection. Intravenous and oral formulations containing granisetron are approved for the prevention of acute-onset CINV but not for delayed-onset CINV. The company selected granisetron because it has an established record of safety and efficacy and is widely prescribed by physicians.
For more information, visit the A.P. Pharma Web site.