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WASHINGTON -- The Food and Drug Administration today approved the combination antiemetic NEPA (netupitant/palonosetron, Akynzeo) for management of chemotherapy-induced nausea and vomiting (CINV).

NEPA consists of a fixed dose of the selective NK₁ receptor inhibitor netupitant and the 5-HT₃ receptor antagonist palonosetron (Aloxi), combined in a single capsule. Originally approved for CINV in 2008, palonosetron prevents nausea and vomiting during the first 24 hours (acute phase) after starting chemotherapy. Netupitant prevents both acute-phase and late-phase (25 to 120 hours) CINV.

"Supportive care products, such as Akynzeo, help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy,", of the FDA's Center for Drug Evaluation and Research, said in a statement.

According to the statement, NEPA established its effectiveness in two randomized clinical trials involving a total of 1,720 patients treated with chemotherapy. Patients received either the fixed-dose combination or palonosetron alone. The primary endpoint of both trials was the prevention of vomiting during the acute, delayed, and overall phases after initiation of chemotherapy.

The first of the two trials showed that NEPA prevented acute-phase vomiting in 98.5% of patients, delayed-phase vomiting in 90.4%, and overall in 89.6% of patients. Corresponding rates of vomiting prevention in the palonosetron arm were 89.7%, 80.1%, and 76.5%. The second trial yielded similar results, according to the FDA.

The two studies were published during the summer, along with a third trial of NEPA, in the same issue of . The third trial evaluated NEPA effectiveness across multiple cycles of chemotherapy, whereas the other two limited investigation to the first cycle of chemotherapy. The multicycle evaluation showed that NEPA plus dexamethasone improved control of CINV during the first cycle, in all subsequent cycles, and overall, as compared with the combination of aprepitant (Emend), palonosetron, and dexamethasone.

Adverse effects associated with NEPA in clinical trials included headache, asthenia, fatigue, dyspepsia, and constipation.

NEPA is distributed and marketed in the U.S. by Eisai in Woodcliff Lake, N.J., under a licensing agreement with Helsinn Healthcare of Lugano, Switzerland.

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