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Chemo Nausea Patch Approved
Sept. 15, 2008 -- The FDA has approved Sancuso, a five-day patch that fights nausea from cancer chemotherapy.
Sancuso continuously delivers a steady dose of a drug called granisetron, which blocks serotonin receptors and helps prevent nausea.
Nausea is a common side effect of chemotherapy. Not all chemotherapy patients experience this side effect, but it can be life- threatening. Some patients have to prematurely stop their cancer treatment because of severe nausea and vomiting.
Granisetron, delivered by injection or orally via tablets or solution, is sold under the brand name Kytril by Roche Pharmaceuticals. The Sancuso patch is from Scotland-based ProStrakan International.
"A patch that can be applied before treatment, releasing medication consistently into the bloodstream over a number of days, has the potential to impact patient comfort and quality of life," oncology nurse practitioner Barbara Rogers, CRNP, of Fox Chase Cancer Center, said in a ProStrakan news release.
The transparent Sancuso patch is applied to the upper arm.
The FDA approval was based on results from a Phase III clinical trial in which Sancuso was compared with once-daily oral granisetron and placebo. The patch prevented chemotherapy-induced nausea and vomiting as well as the oral product did, according to the company news release.
The most important Sancuso side effect in the clinical trial was constipation. Overall, nearly 9% of patients experienced adverse reactions related to the drug, but the drug was generally well tolerated.
According to the FDA, Sancuso may be used to prevent nausea and vomiting in patients receiving nausea-inducing chemotherapy regimens for up to five consecutive days.
ProStrakan says Sancuso should be available to patients in December.
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