After a nearly six year regulatory approval process, Heron Therapeutics has finally received US Food and Drug Administration (FDA) approval for its long-acting antinausea drug, Sustol. The drug provides prolonged relief from nausea of over five days, for cancer patients undergoing chemotherapy.
The long-acting antinausea effect provided by Sustol is a significant improvement over currently-approved antiemetic drugs. The drug has been approved to be prescribed alongside some of the most commonly-used chemotherapy agents.
“The Sustol clinical trial populations and results are highly representative of cancer patients in our real-world clinical practice,” said Dr. Jeffrey Vacirca, Chief Executive Officer and Director of Clinical Research, North Shore Hematology Oncology Associates and Vice President, Community Oncology Alliance. “Use of moderately emetogenic chemotherapy (MEC) regimens is widespread, and anthracycline and cyclophosphamide (AC)-based regimens are among the most commonly prescribed highly emetogenic chemotherapy regimens.
“The most significant challenge for my breast cancer patients receiving AC is chemotherapy-induced nausea and vomiting (CINV),” Vacirca continued. “Sustol represents a better option to manage this devastating side effect of therapy.”
The FDA approval for Sustol is the result of three applications filed by Heron since 2010. The first FDA rejection was based on the regulatory agency’s need for more data on the drug, while the second was the result of data analysis and manufacturing issues.
With their FDA approval for Sustol in hand, Heron plans to start marketing the drug in the US during the fourth quarter of this year. The drug is the first to utilize the company’s polymer-based Biochronomer drug delivery technology.
Heron’s Biochronomer technology allows the therapeutic levels of the drug to remain stable over five days after Sustol is taken. Sustol is a serotonin-3 (5-HT3) receptor antagonist to be administered via injection.
“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 Dr. Ralph V. 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 5 days.”