Heron Therapeutics Announces U.S. FDA Approval of Cinvanti™ (Aprepitant)
Heron Therapeutics Announces U.S. FDA Approval of Cinvanti (aprepitant) injectable emulsion for the prevention of acute and delayed Chemotherapy Induced Nausea and Vomiting (CINV). 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 including high-dose cisplatin and initial and repeat courses of moderately emetogenic cancer chemotherapy.
Cinvanti injectable emulsion contains the active ingredient, aprepitant. Aprepitant is a lipophilic, poorly water soluble substance P/neurokinin 1 (NK1) receptor antagonist, an antiemetic agent. It is the first and only polysorbate 80-free, intravenous formulation of an NK1 receptor antagonist indicated for the prevention of acute and delayed CINV. The emulsion contains the following inactive ingredients: egg lecithin, ethanol, sodium oleate, soybean oil, sucrose and water for injection. In the past, pharmaceutical formulations containing polysorbate 80 have been linked to hypersensitivity reactions, including anaphylaxis and irritation of blood vessels resulting in infusion-site pain.
Cinvanti is an excellent example of a parenteral emulsion with egg phospholipid as superior emulsifier, compared to synthetic emulsifiers which may rise the risk for anaphylactoid reactions, to solubilize a lipophilic dug substance.
The U.S. Commercial Launch of Cinvanti is planned for January 2018,
Heron Therapeutics, Press Release, November 9th, 2017