Emend for Oral Suspension Approved by the FDA

The Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Emend (aprepitant; Merck) for oral suspension for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients aged ≥6 months old.

Emend for oral suspension, in combination with other antiemetics, is specifically indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin; and for nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Aprepitant is a selective high-affinity antagonist of human substance P/neurokinin 1 (NK1) receptors. Aprepitant has little or no affinity for serotonin (5-HT3), dopamine, and corticosteroid receptors, the targets of existing therapies for chemotherapy-induced nausea and vomiting and postoperative nausea and vomiting (PONV).

Emend is currently available as 40mg, 80mg, and 125mg strength capsules, as well as 115mg/vial and 150mg/vial strength powder for IV infusion. The new oral suspension will be available as a 125mg strength powder for oral suspension in a single-use pouch with dispenser.

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