Heron Therapeutics gets FDA approval for chemotherapy-induced nausea drug
pharmafile | August 11, 2016 | News story | Research and Development, Sales and Marketing | FDA, chemotherapy-induced nausea, granisetron, heron therapeutics, sustol
Heron Therapeutics has announced that it has received US Food and Drug Administration (FDA) approval for Sustol (granisetron) for the treatment of chemotherapy-induced nausea and vomiting (CINV).
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 or anthracycline and cyclophosphamide combination chemotherapy regimens.
The drug utilises Heron’s Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of the Sustol for more than five days.
In Phase III trials, Sustol proved efficacy in both the acute phase (day one following chemotherapy) and the delayed phase (days two to five after chemotherapy).
Ralph Boccia, medical director at the center for cancer and blood disorders, says: “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. In our experience, other 5-HT3 receptor antagonists, including Aloxi (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.”
Robert Rosen, president of Heron Therapeutics, comments: “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.”
Sean Murray
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