A New Drug Application (NDA) has been submitted to the Food and Drug Administration (FDA) for HTX-019 (aprepitant) injectable emulsion for the prevention of postoperative nausea and vomiting (PONV) in adults.
HTX-019 is a proprietary intravenous (IV) injectable emulsion formulation designed to directly deliver aprepitant, a substance P/neurokinin-1 (NK1) receptor antagonist, as a 30-second IV injection. HTX-019 is identical to the FDA-approved Cinvanti injectable emulsion formulation. The investigational treatment is intended to provide convenient, rapid exposure compared with the oral aprepitant formulation which is administered 1 to 3 hours prior to anesthesia.
The NDA submission is supported by data from a phase 1 trial which demonstrated that 32mg of HTX-019 as a 30-second IV injection was bioequivalent to oral aprepitant 40mg for the prevention of PONV. HTX-019 was also well tolerated with a similar safety profile to oral aprepitant.
“In a recent Cochrane Meta-Analysis, aprepitant was found to be the most effective agent for PONV prevention with activity similar to two-drug combinations. In fact, the use of oral aprepitant has grown by almost 80% in the past three years without any promotional efforts. Our IV formulation is designed to directly deliver the active form of the drug, aprepitant, to patients over 30 seconds so it can take effect much more quickly than when taken orally,” said Barry Quart, PharmD, Chairman and CEO of Heron. “The HTX-019 NDA was filed with the same FDA division that previously approved Cinvanti without delays.”
Heron Therapeutics announces submission of HTX-019 NDA for the prevention of postoperative nausea and vomiting to FDA. News release. Heron Therapeutics, Inc. Accessed November 18, 2021. https://prnmedia.prnewswire.com/news-releases/heron-therapeutics-announces-submission-of-htx-019-nda-for-the-prevention-of-postoperative-nausea-and-vomiting-to-fda-301427958.html.