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FDA Approves Drug to Prevent Chemotherapy-Induced Nausea and Vomiting

FDA Approves Drug to Prevent Chemotherapy-Induced Nausea and Vomiting

By: Sarah Massey, M.Sc.

Posted on: in News | Pharmaceutical Marketing News

The FDA has approved the antiemetic drug Varubi (rolapitant), for the prevention of nausea and vomiting associated with chemotherapy treatment. According to the FDA, Varubi is a, “human substance P/neurokinin-1 (NK-1) receptor antagonist,” which has been approved for use in adults in combination with other antiemetics.

The safety and efficacy of the drug was evaluated during three distinct phase 3 clinical trials, which involved a total 2,800 patients. The trial results showed evidence that when Varubi was administered along with two other commonly prescribed antiemetics – granisetron and dexamethasone – the drug was more effective at preventing nausea and vomiting compared to the placebo.

While patients were undergoing chemotherapy, those that received Varubi reported less vomiting used fewer recue medications to prevent nausea and vomiting. Nausea and vomiting are common side effects of chemotherapy for cancer treatment, and unpleasant symptoms can last multiple days following treatment.

Vomiting can also lead to further issues including fatigue, difficultly concentrating and delayed wound healing. If vomiting is left untreated, it can lead to more severe complications including malnutrition, dehydration and weight loss. These serious complications may lead to hospitalization.

The most common side effects associated with Varubi use include low white blood cell count (neutropenia), hiccups, dizziness and reduced appetite. The side effects of Varubi are considerably less dangerous than those of prolonged vomiting.

Nausea and vomiting associated with chemotherapy treatment is general classified into three distinct categories: acute symptoms occur within 24 hours of treatment, delayed phase symptoms lasts for up to a week following treatment, and anticipatory symptoms occur before treatment is administered. Varubi has been approved for prevention of delayed phase nausea and vomiting.

The three trials tested Varubi’s effectiveness at preventing nausea and vomiting when paired with moderately emetogenic, and highly emetogeneic chemotherapy drugs. The most emetogenic drugs include cisplatin, and cyclophosphamide in conjunction with anthracycline.

According to Dr. Amy Egan, deputy director of the Office of Drug Evaluation III in the Center for Drug Evaluation and Research at the FDA, “Chemotherapy-induced nausea and vomiting remains a major issue that can disrupt patients’ lives, and sometimes their therapy. Approval provides cancer patients with another treatment option for the prevention of the delayed phase of nausea and vomiting caused by chemotherapy.”

Chemotherapy often induces nausea and vomiting because it affects nerve centers in the brain as well as in the digestive tract, which trigger activation of the vomiting reflex pathway. Approximately 7 or 8 out of every 10 patients receiving chemotherapy experience some form of these symptoms, according to the American Cancer Society.

Antemetic drugs are able to block the receptors involved in triggering the vomiting pathway. For example, granisetron blocks the serotonin receptor 5-HT3 found in the brain and the digestive tract. Varubi blocks the P/neurokinin 1 (NK-1) receptor which has been shown to be responsible for delayed phase chemotherapy-induced antemetic symptoms.

“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,” says Lonnie Moulder, CEO of Tesaro Inc., the company responsible for marketing Varubi.

Varubi should not be taken by patients who are also on certain antipsychotics including thioridazine, as it may interfere with the enzymes responsible for drug metabolism.

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