GlaxoSmithKline (GSK) recently announced the submission of a new drug application to the US Food and Drug Administration for casopitant (Rezonic, Zunrisa), a novel, investigational NK-1 receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) as an add-on therapy to the standard dual therapy of a 5-HT3 receptor antagonist, such as ondansetron (Zofran), and dexamethasone. Applications have been submitted for both the IV and oral formulations. The NDA submission also included the proposed indication of the prevention of postoperative nausea and vomiting.
NK-1 receptor antagonists like casopitant complement 5-HT3 receptor antagonists by acting on a different, but also important neurotransmitter system responsible for nausea and vomiting.
New data from two phase III trials demonstrated a significant and clinically meaningful reduction in the number of patients experiencing CINV. Adding a single oral dose regimen of casopitant to ondansetron and dexamethasone achieved this effect in patients taking highly emetogenic chemotherapy (HEC) as well as those on moderately emetogenic chemotherapy (MEC) treatment regimens.