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New Drug Akynzeo Gets FDA Approval to Treat Nausea, Vomiting Linked with Chemotherapy

First Posted: Oct 11, 2014 04:32 AM EDT
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The U.S. FDA panel gave a nod to a new drug, Akynzeo, to treat nausea and vomiting linked with chemotherapy.

In a latest announcement, the U.S. Food and Drug Administration revealed that it had approved a novel drug marketed by Eisai, called Akynzeo (netupitant and Palonosetron). This capsule is meant to treat nausea and vomiting in those undergoing cancer chemotherapy.

This newly released drug is a fixed combinated capsule that has two drugs mainly the 'oral palonosetron' that approved in 2008 to treat nausea and vomiting during the first 24 hours on the start of cancer chemotherapy and 'netupitant' the latest drug that prevents nausea and vomiting during acute as well as delayed phase after the start of the cancer chemotherapy.

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

In order to test the effectiveness and safety of the new drug, the researchers established two different clinical trials that included 1,720 participants who were receiving chemotherapy. As a part of the study, the participants were randomly assigned to receive either Akynzeo or oral palonosetron. The trails were designed to specially measure whether the study drugs was successful in preventing any vomiting episode during the acute, delayed and overall phase after the initiation of the chemotherapy sessions.

The researchers noticed that in the first trail, 98.5 percent, 90.4 percent and 89.6 percent of those treated with Akynzeo did not experience any vomiting, nor did they need a rescue medication for nausea during the acute, delayed or overall phases. In contrast to this, 89.7 percent, 80.1 percent and 76.5 percent of the participants treated with oral palonosetron did not experience any vomiting or they use any medication to treat nausea during the acute, delayed and overall phases. Similar results were observed during the second trials.

The common side effects noticed among those treated with Akynzeo included headache, weakness, fatigue, indigestion and constipation.

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