FDA approves Heron’s Sustol for chemotherapy-induced nausea and vomiting

Sustol is the first extended-release serotonin-3 (5-HT3) receptor antagonist approved to prevent acute and delayed nausea and vomiting associated with both moderately emetogenic chemotherapy and anthracycline and cyclophosphamide combination chemotherapy regimens.

It uses Heron’s Biochronomer drug-delivery technology to maintain therapeutic levels of the medication for at least five days, covering the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).

A global, Phase 3 program, composed of two, large clinical trials, assessed Sustol’s efficacy and safety in over 2,000 patients with cancer.

The drug’s efficacy in avoiding nausea and vomiting was examined in both the phases.

Heron Therapeutics president Robert Rosen said: "The approval of Sustol is a major step in Heron’s evolution into a fully-integrated biopharmaceutical company with both development and commercial capabilities.

“Our focus now turns to ensuring patients have access to this important therapy. We look forward to collaborating with the oncology community to make Sustol available in the fourth quarter of this year.”

Heron said Sustol is contraindicated in patients with hypersensitivity to granisetron, any of the medication’s components, or any other 5-HT3 receptor antagonist.

There were hypersensitivity reactions, which could last for about 7 days or longer after Sustol administration, with the possibility of an extended course.

Heron said if a reaction takes place, patients should administer correct treatment and monitor until signs and symptoms resolve.

Image: FDA Building 31 houses the Office of the Commissioner and the Office of Regulatory Affairs. Photo: courtesy of The U.S. Food and Drug Administration.