FDA Approves Nabilone to Treat Chemotherapy-Induced Nausea and Vomiting

Valeant Pharmaceuticals International announced that the US Food and Drug Administration (FDA) has given marketing approval for nabilone (Cesamet, CII) oral capsules. Nabilone is used to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Nabilone is a synthetic cannabinoid that is thought to act as an omnineuromodulator-interacting with the cannabinoid receptor CB1, which is present throughout the nervous system. This receptor is involved in regulating nausea and vomiting. Because of this omnineuromodulation, the mechanism of action for nabilone is significantly different from conventional antiemetics. Nabilone has a long duration of action, which allows for less frequent dosing, typically twice daily.

The American Cancer Society estimates that there will be nearly 1.4 million new cancer cases in 2006. For patients on chemotherapy, stomach upset may occur and trigger a strong urge to vomit. Approximately 70% to 80% of all patients receiving chemotherapy experience chemotherapy-induced nausea and vomiting. Although the use of antiemetic agents decreases the incidence and severity of such reactions, symptoms continue to occur in 40% to 60% percent of patients.

"There is a need for cannabinoids, such as Cesamet, for patients who have exhausted conventional treatments but are still coping with the debilitating side effects of chemotherapy," said Neal Slatkin, md, dabpm, director, Department of Supportive Care, Pain and Palliative Medicine at City of Hope, Duarte, Calif. "[Chemotherapy-induced nausea and vomiting] dramatically impacts cancer patients' quality of life and can result in patients refusing courses of chemotherapy, which minimizes chances for the best possible outcome."