Injectable emulsion for prevention of acute and delayed nausea and vomiting approved

Heron Therapeutics announced that the FDA has approved Heron's supplemental New Drug Application (sNDA) for Cinvanti (aprepitant) injectable emulsion, for intravenous (IV) use for the prevention of acute and delayed nausea and vomiting. The sNDA requested FDA approval to expand the administration of Cinvanti beyond the already approved administration method (a 30-minute IV infusion) to include a 2-minute IV injection.

Cinvanti was initially 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 highly emetogenic cancer chemotherapy (HEC) and moderately emetogenic cancer chemotherapy (MEC). Results from two 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. The new method of administration for Cinvanti was approved based on a third study demonstrating bioequivalence and a comparable safety profile for Cinvanti given as a 30-minute IV infusion and as a 2-minute IV Cinvanti , also referred to as an IV push.

Comment: CINVANTI is the first and only polysorbate 80-free, IV formulation of an NK1 receptor antagonist (RA) indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Cinvanti is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is the only single-agent NK1 RA to significantly reduce CINV in both the acute phase (0 – 24 hours after chemotherapy) and the delayed phase (24 – 120 hours after chemotherapy).