Heron Therapeutics announced that the Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Cinvanti (aprepitant) to expand administration to include a 2-minute intravenous (IV) injection, in addition to the already approved 30-minute IV infusion.
Cinvanti is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV), in combination with other antiemetics. It has been shown to significantly reduce CINV in both the acute phase (0–24hrs post-chemotherapy) and the delayed phase (24–120hrs post-chemotherapy).
The expanded approval was supported by data indicating bioequivalence and comparable safety with Cinvanti given as a 30-minute IV infusion and as a 2-minute IV push. “This approval will enable physicians to leverage the operational advantages of this method of administration and will contribute to a reduction in total patient time spent in the infusion suite,” stated Rudolph M. Navari, MD, PhD, University of Alabama, Birmingham School of Medicine, Division of Hematology Oncology.
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Cinvanti, a substance P/neurokinin-1 (NK1) receptor antagonist, is free of polysorbate 80 and other synthetic surfactants. Polysorbate 80 has been associated with hypersensitivity reactions such as anaphylaxis and irritation of blood vessels.
For more information call (844) 437-6611 or visit Cinvanti.com.
