Sustol NDA Resubmission Accepted by FDA
Heron Therapeutics announced that the Food and Drug Administration (FDA) has accepted for review the 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 NDA resubmission is based on results from MAGIC, a multi-center, placebo-controlled, Phase 3 study for the prevention of delayed CINV associated with HEC regimens. It is the only Phase 3 CINV prophylaxis study in a HEC population performed to date to use the currently recommended, standard-of-care, three-drug regimen as a comparator: a 5-HT3 receptor antagonist, fosaprepitant, and dexamethasone. The primary endpoint was achieved and the percentage of patients who achieved a Complete Response in the delayed phase was significantly higher in the Sustol arm compared with the comparator arm (P=0.014).
Heron previously submitted to the FDA data from an earlier Phase 3 study which demonstrated Sustol's efficacy in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens. In July 2015, Heron resubmitted the Sustol NDA.
Sustol Injection, extended release, is a long-acting formulation of granisetron, a 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, which utilizes Heron's proprietary Biochronomer drug delivery technology. Sustol is the first agent in the class to demonstrate efficacy in reducing the incidence of delayed CINV in patients receiving HEC.
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