US regulators have approved a new, long-acting treatment to stave off acute and delayed chemotherapy-related nausea and vomiting.
More specifically, the decision clears the use of Sustol (granisetron) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy or anthracycline and cyclophosphamide combination chemotherapy regimens.
Sustol is an extended-release, injectable 5-HT3 receptor antagonist that utilises Heron's Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for more than five days, thereby 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," said Ralph Boccia, 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 five days."
The approval marks the first of any product using the firm's Biochromer drug delivery technology.
Heron says it hopes Sustol will be available to the oncology community in the fourth quarter.