FDA Approves Antiemetic

On October 10, 2014, an oral fixed-dose combination antiemetic (netupitant and palonosetron, marketed as Akynzeo by Helsinn/Eisai) was approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV). The antiemetic is a combination of the tachykinin NK₁ receptor antagonist netupitant (300 mg dose) and the 5-HT₃ receptor antagonist palonosetron (0.5 mg dose).

The FDA noted that palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase and netupitant, a new drug, prevents nausea and vomiting during both the acute and delayed phases.

The antiemetic’s effectiveness was confirmed in two clinical trials of 1,720 patients receiving chemotherapy. The trials compared the new combination against oral palonosetron, and found that the combination was more effective in preventing CINV. In the first trial, the percentage of patients who did not experience any vomiting or require rescue medication for nausea in the acute phase of CINV was 98.5% with the combination versus 89.7% with palonosetron alone. The percentage that did not experience delayed nausea and vomiting was 90.4% of the patients receiving the combination antiemetic versus 80.1% for those receiving only palonosetron,

Common adverse effects reported with the combination antiemetic in the clinical trials were headache, asthenia, fatigue, indigestion dyspepsia, and constipation. The FDA’s press announcement may be found at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418375.htm.