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. CINV can be a serious, feared and distressing side effect of chemotherapy for patients and their families. 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.
The details can be read here.
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