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The Food and Drug Administration (FDA) has approved Akynzeo (netupitant and palonosetron; Eisai) to treat nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a fixed-dose combination capsule consisting of oral palonosetron, which prevents nausea and vomiting during the acute phase (within the first 24 hours) after the start of cancer chemotherapy and netupitant, which prevents nausea and vomiting during both the acute phase and delayed phase (from 25–120 hours) after the start of cancer chemotherapy.
The effectiveness of Akynzeo was established in two clinical trials with 1,720 participants receiving cancer chemotherapy. Participants were randomized to receive Akynzeo or oral palonosetron. The trials were designed to measure whether the study drugs prevented any vomiting episodes in the acute, delayed and overall phases after the start of cancer chemotherapy.
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Results of the first trial demonstrated that 98.5%, 90.4% and 89.6% of Akynzeo-treated participants did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases, respectively. In contrast, 89.7%, 80.1% and 76.5% of participants treated with oral palonosetron did not experience any vomiting or require rescue medication for nausea during the acute, delayed and overall phases, respectively. The second trial showed similar results.
Akynzeo will be available as 300mg netupitant/0.5mg palonosetron strength gelatin coated capsules.
For more information call (888) 422-4743 or visit Eisai.com.
