FDA approves Cinvanti for prevention of nausea and vomiting associated with chemotherapy - Heron Therapeutics.

Heron Therapeutics, Inc.has announced that the FDA has approved Cinvanti (aprepitant) injectable emulsion, for intravenous infusion. Cinvanti is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

With this approval, Heron now is the only company with approved injectable therapies that address the two primary mechanisms of CINV: Sustol, a serotonin-3 (5-HT3) receptor antagonist, and Cinvanti, an NK1 receptor antagonist. Cinvanti is the first and only polysorbate 80-free, intravenous formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed CINV. Cinvanti is the first intravenous formulation to directly deliver aprepitant, the active ingredient in Emend capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 receptor antagonist to significantly reduce CINV in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy). Cinvanti does not contain polysorbate 80 or any other synthetic surfactant. Pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain.

Cinvanti was approved based on data demonstrating the bioequivalence of Cinvanti to Emend IV (fosaprepitant), supporting its efficacy for the prevention of acute and delayed CINV following HEC and MEC. Results from 2 pivotal randomized, cross-over bioequivalence studies of Cinvanti and Emend IV showed subjects receiving Cinvanti reported fewer adverse events than those receiving Emend IV, including substantially fewer infusion-site reactions.