publication date: Oct. 10, 2014
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FDA Approves Oral Akynzeo For Treatment-Related Nausea
FDA approved Akynzeo (netupitant and palonosetron) to treat nausea and vomiting in patients undergoing cancer chemotherapy.
Akynzeo is a fixed combination capsule comprised of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting during the acute phase after the start of cancer chemotherapy. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase after the start of cancer chemotherapy.
Akynzeo’s effectiveness was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned 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.
Results of the first trial showed that 98.5 percent, 90.4 percent and 89.6 percent 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 percent, 80.1 percent and 76.5 percent 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 is distributed and marketed by Eisai Inc. under license from Switzerland-based Helsinn Healthcare S.A.
FDA granted Orphan Drug Designation for DNX-2401, a conditionally-replicative oncolytic adenovirus for malignant glioma. Under the designation, companies are provided with development and commercial incentives for designated compounds. DNX-2401 has already been granted fast track status and is currently being evaluated in clinical studies in the U.S. … Continue reading 40-38 Drugs and Targets
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