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GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic(TM)/Zunrisa(TM) (Casopitant)
Date:5/29/2008

Data Showed Clinically Meaningful Benefits for Patients with Chemotherapy-Induced Nausea and Vomiting

PHILADELPHIA and LONDON, May 29 /PRNewswire-USNewswire/ -- GlaxoSmithKline (GSK) today announced the submission of a new drug application to the U.S. Food and Drug Administration and new data from two Phase III trials for Rezonic(TM)/Zunrisa(TM) (casopitant), a novel, investigational NK-1 receptor antagonist. The data demonstrated a significant and clinically meaningful reduction in the number of patients experiencing chemotherapy-induced nausea and vomiting (CINV). Adding a single oral dose regimen of casopitant to the standard dual therapy of Zofran(R) (ondansetron HCI) and dexamethasone, achieved this effect in patients taking highly emetogenic chemotherapy (HEC) and those on moderately emetogenic chemotherapy (MEC) treatment regimens.(1,2) CINV can be a serious, feared and distressing side effect of chemotherapy for patients and their families.(3) CINV can last for about five days and the risk of nausea and vomiting without prophylaxis is greater than 90 percent for patients receiving HEC and 30-90 percent for patients receiving MEC.(4,5)

Data from the two Phase III clinical trials demonstrated complete response rates of 86 percent for those patients given a single oral dose of casopitant together with the standard dual therapy in the HEC trial, and 73 percent for patients given either single oral or three-day oral doses of casopitant together with the standard dual therapy in the MEC trial.(1,2) This prophylactic treatment resulted in clinically meaningful and statistically significant improvements compared to controls.(1,2) To achieve complete response, patients had no vomiting or retching and took no rescue medications for five days following chemotherapy treatment.(1,2) These data for the single dose regimen - in addition to results for three-day oral and three-day IV/oral regimens - will be unveiled this week at the 44th Annual Meeting
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SOURCE GlaxoSmithKline
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