Heron Therapeutics a biotechnology company focused on improving the lives of patients by developing medicines that address major unmet medical needs, has announced that the FDA has accepted for review Heron’s New Drug Application (NDA) resubmission for SUSTOL® (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016.
The NDA filing includes data from the MAGIC study, Heron’s recently completed, multi-center, placebo-controlled, Phase 3 study of SUSTOL for the prevention of delayed CINV in more than 900 patients receiving HEC regimens. Data from an earlier Phase 3 study of more than 1,300 patients, which were previously submitted to the FDA, demonstrated SUSTOL’s efficacy in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens.
“We believe that the MAGIC study has demonstrated SUSTOL’s superior ability to improve the lives of patients suffering from the debilitating effects of nausea and vomiting associated with chemotherapy compared to the current standard-of-care,” commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. “We look forward to working closely with the FDA during the review of the SUSTOL NDA and moving forward with commercial planning in anticipation of SUSTOL’s potential launch early next year.”