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Future Oncol. 2018 Nov;14(27):2849-2859. doi: 10.2217/fon-2018-0311. Epub 2018 Jun 6.

Safety of HTX-019 (intravenous aprepitant) and fosaprepitant in healthy subjects.

Author information

1
Pharmaceutical & Translational Sciences, Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.
2
Clinical Operations, Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.
3
Biometrics, Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.
4
Drug Development, Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.
5
Clinical, Heron Therapeutics, Inc., 4242 Campus Point Court, Suite 200, San Diego, CA 92121, USA.

Abstract

AIM:

Evaluate safety of HTX-019, a novel polysorbate 80- and synthetic surfactant-free intravenous formulation of neurokinin 1 receptor antagonist aprepitant for chemotherapy-induced nausea and vomiting.

METHODS:

Two open-label, randomized, two-way crossover studies evaluated treatment-emergent adverse events (TEAEs) in 200 healthy subjects. Subjects received HTX-019 130 mg (30-min infusion) and fosaprepitant 150 mg (20- or 30-min infusion), with ≥7-day washout between doses.

RESULTS:

Less than or equal to 30 min after start of infusion, TEAEs occurred in 5 (3%) HTX-019 and 30 (15%) fosaprepitant recipients. No HTX-019 recipients had infusion-site adverse events, versus 15 (8%) fosaprepitant recipients. Treatment-related dyspnea occurred in one HTX-019 and six fosaprepitant recipients. No severe/serious TEAEs occurred; all TEAEs resolved.

CONCLUSION:

HTX-019 may provide a safer aprepitant formulation than fosaprepitant for chemotherapy-induced nausea and vomiting prevention.

KEYWORDS:

antiemetics; aprepitant; safety

PMID:
29873529
DOI:
10.2217/fon-2018-0311

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