FDA approves Sustol (granisetron) extended-release injection for the prevention of acute and delayed nausea and vomiting.- Heron Therapeutics

Heron Therapeutics, Inc. announced that the FDA has approved Sustol (granisetron) extended-release injection. Sustol is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. Sustol is an extended-release, injectable 5-HT3 receptor antagonist that utilizes Heron�s Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for ?5 days, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).

�Despite advances in the management of CINV, up to half of patients receiving chemotherapy can still experience CINV, with delayed CINV being particularly challenging to control,� commented Ralph V. Boccia, MD, FACP, Medical Director, Center for Cancer and Blood Disorders. �In our experience, other 5-HT3 receptor antagonists, including palonosetron, are generally effective for 48 hours or less. SUSTOL, due to its extended-release profile, represents a novel option that can protect patients from CINV for a full 5 days".