Sustol NDA Resubmitted for Chemotherapy-Induced Nausea and Vomiting
Heron Therapeutics announced that it has resubmitted its New Drug Application (NDA) for Sustol (granisetron) injection, extended release to the Food and Drug Administration (FDA) 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 NDA submission includes data from the MAGIC study, a Phase 3 multi-center, placebo-controlled study in patients receiving HEC agents. The MAGIC study evaluated the efficacy and safety of Sustol as part of a three-drug regimen with IV fosaprepitant and IV/oral dexamethasone for the prevention of delayed nausea and vomiting in patients receiving HEC.
The primary endpoint in the MAGIC study was achieved. The percentage of patients who achieved a Complete Response was significantly higher in the Sustol arm compared with the comparator arm (P=0.014). Significant benefit was also observed in the reduction in episodes of nausea. Data from a previous Phase 3 study of more than 1,300 patients, which was 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.
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