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Title: FDA Approves Granisetron Patch for Chemotherapy-Induced Nausea, Vomiting
URL: http://www.pslgroup.com/dg/22C216.htm
Doctor's Guide
September 15, 2008

NEW YORK -- September 15, 2008 -- The US Food and Drug Administration (FDA) has approved Granisetron Transdermal System (Sancuso) for control of nausea and vomiting in patients receiving a moderately and/or highly nausea-inducing chemotherapy regimen.

"We've made significant progress in our understanding of chemotherapy and how to prevent its side effects, yet undergoing chemotherapy remains a challenging experience on many levels," said Barbara Rogers, Fox Chase Cancer Center, Philadelphia, Pennsylvania.

"We should have zero tolerance for chemotherapy-induced nausea and vomiting. 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."

The approval is based on the results of a multicenter phase III randomised, double-blind, controlled study comparing the efficacy, tolerability and safety of the granisetron patch with once-daily oral granisetron 2 mg.

The trial included 641 patients who received moderately or highly nausea-inducing multi-day chemotherapy, and met its primary endpoint of achieving complete control of chemotherapy-induced nausea and vomiting (CINV), working as well as oral granisetron.

Complete control was defined as no vomiting and/or retching, no more than mild nausea, and no rescue medication from first administration of the granisetron patch until 24 hours after the last day of chemotherapy.

The granisetron patch was generally well-tolerated by patients in clinical trials. The most common adverse reaction in patients (8.7%) was constipation. Application site reactions were reported but were mild and did not lead to discontinuation of use. The incidence of skin reactions was comparable to placebo.

SOURCE: ProStrakan

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