Heron Therapeutics announces submission of NDA for Cinvanti, or HTX-019
Heron Therapeutics announced submission of the New Drug Application for CINVANTI, or HTX-019, the first polysorbate 80-free, intravenous formulation of aprepitant for the prevention of CINV, to the U.S. Food and Drug Administration. Aprepitant belongs to a class of agents known as NK1 receptor antagonists, which are often used in combination with 5-HT3 receptor antagonists for the prevention of CINV. The NDA filing includes data demonstrating the bioequivalence of CINVANTI to EMEND IV, supporting its efficacy for the prevention of both acute and delayed CINV with both moderately emetogenic chemotherapy and highly emetogenic chemotherapy. Results also showed CINVANTI was better tolerated than EMEND IV, with significantly fewer adverse events reported with CINVANTI.