Anti-Nausea Patch For Chemo Patients Gets FDA Approval
Submitted by Carina Rose on Tue, 09/16/2008 - 05:58
The Food and Drug Administration said it has approved the first anti-nausea patch for use by cancer patients on Monday. Sancuso, the patch worn on the arm delivers granisetron, a widely used anti-nausea medicine through the skin. Expected to be available by the end of the year, the patch would offer relief from the debilitating nausea that often accompanies chemotherapy.
The patch Sancuso works by continuously delivering a steady dose of granisetron, which blocks serotonin receptors and helps prevent nausea. Barbara Rogers, a nurse practitioner who works at Fox Chase Cancer Center in Philadelphia and specializes in cancer treatment said, "It will be another way that we can address nausea and vomiting, coming from a route that we haven't had before. The patch is a nice option." She is also a consultant to ProStrakan, the Scottish company that developed the patch
About a million people undergo chemotherapy every year, and though not all but about 70 % develop nausea as a result. As many of the patients develop nausea after they are sent home, the only recourse they had is anti-nausea pills which many experience difficulty in swallowing. Some patients even prematurely stop their cancer treatment due to the severity of the nausea and vomiting. Till now Granisetron, sold under the brand name Kytril by Roche Pharmaceuticals was either delivered by injection or orally via tablets or solution. 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," said Rogers, in a ProStrakan news release. "The main benefit will be for people who have difficulty taking oral medications," Rogers added. But other patients could also benefit, she said
The transparent Sancuso patch is applied to the upper arm and a single patch is designed to maintain a steady level of the anti-nausea medicine in the body for several days. Medical professionals feel that while treating cancer patients it is important to eliminate nausea as a side effect of chemotherapy, in the belief that it will help the patients maintain physical strength and emotional energy.
Results from a Phase III clinical trial in which Sancuso was compared with once-daily oral granisetron and a placebo showed favorable results which led to the FDA approval. According to the company news release the patch prevented chemotherapy-induced nausea and vomiting as well as the oral product did.
In the clinical trial Sancuso’s side effect was constipation with, nearly 9% of patients experiencing adverse reactions related to the drug, though overall the drug was well tolerated. The FDA says Sancuso may be used in patients receiving nausea-inducing chemotherapy regimens for up to five consecutive days. ProStrakan says Sancuso should be available to patients in December.
