FDA approves chemotherapy anti-nausea drug

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An anti-nausea drug created to battle the side effects of chemotherapy has been approved by the US Food and Drug Administration (FDA).

The name of the drug approved by the FDA is Varubi, chemically known as rolapitant and marketed by Tesaro Inc. The drug is intended to treat nausea and vomiting among chemotherapy patients. The outlet added that nausea and vomiting are two of the most common side effects of the anti-cancer treatment.

In fact, it is experienced by 80 percent of patients. Untreated nausea can lead to dehydration, malnutrition, and weight loss, according to WebMD. All of which could be seriously harmful to cancer patients.

According to Reuters, Varubi blocks neurokinin (NK)-1 receptors from activating in the nervous system. An IV formula of the drug is also being tested by the manufacturer. The outlet added that the drug originally belonged to Opko Health Inc until December 2010 until it was licensed by Tesaro. It is the first drug by the company to receive an FDA approval.

"The approval of VARUBI, our first product, represents a significant milestone in TESARO's evolution into an integrated biopharmaceutical company with strong development and commercialization capabilities," Tesaro CEO Lonnie Moulder said in the report by GlobeNewsWire.

Medical Xpress reports that the FDA have issued a warning that patients taking thioridazine, a drug that treats schizophrenia, should not be taking Varubi because it may cause the patient to have irregular heartbeats.

An article published in the American Cancer Society lists the common side effects of Varubi. Taking the pill may induce hiccups, decreased appetite, dizziness and low white blood cell count (neutropenia).

The article added that the approval of the FDA stems from its three clinical trials. In more than 2,500 cancer patients who were undergoing chemotherapy and experienced nausea and vomiting, researchers gave the participants either Varubi with anti-nausea drugs granisetron and dexamethasone, while some were given a placebo pill with granisetron and dexamethasone. They found that those who were treated with Varubi fared better than those who received the fake pill.

"Results from the Phase 3 trials of VARUBI demonstrated that patients receiving emetogenic chemotherapy agents, including platinum and cyclophosphamide-containing regimens, benefitted from the addition of VARUBI to their antiemetic regimen," Moulder said in a statement, according to the report by Street Insider.

According to the Boston Globe, the company has not announced the price of the drug but it will be sold in the US during the last quarter of this year.

The full prescribing information for VARUBI is published at Varubirx.com.