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Cesamet cannabis drug gets OK to treat nausea

BY OUR PHARMA CORRESPONDENT
May 17, 2006

Still remaining illegal in the vast majority of the world, the `sacred grass’ of the ancient sages finally got its due in the form of a scientific recognition for one of its most disputed claims—as a potential medicament.

The world’s toughest drug regulator, the Food and Drug Administration of USA, has given approval to sell a drug which has the synthetic version of the active substance in marijuana to treat nausea.

Named Cesamet, the oral capsules contain a cannabinoid – nabilone. Cannabinoids are the active ingredients in marijuana.

Cesamet, which aims to treat nausea and vomiting in cancer patients who have undergone chemo-therapy and don’t adequately respond to conventional treatments. 

Cesamet’s safety and effectiveness was tested in 11 clinical trials totaling more than 300 cancer chemotherapy patients. Five trials compared Cesamet with another drug called Compazine (prochlorperazine) that doesn’t contain cannabinoids. Compazine is a common medication for nausea and vomiting, especially for cancer patients. The other six studies compared Cesamet with a placebo, which contained no medication. 

In all but one study, Cesamet came out on top in all statistical comparisons, meaning that patients using Cesamet had fewer vomiting episodes and less severe nausea, according to Valeant Pharmaceuticals International, the maker of the drug.

However, the drug’s label states that Cesamet, "like other cannabinoids, has complex effects on the central nervous system" and that the drug may work by interacting with cannabinoid receptors (the CB1 receptor) in the brain. 

Patients in those trials who took Cesamet "reported a higher incidence of adverse effects," states the drug’s label. "The most frequent were drowsiness, vertigo, dry mouth, and euphoria," the label states. "However, most of these adverse effects occurring with Cesamet were of mild to moderate severity." 

Cesamet is classified as a "Schedule II" drug, meaning it has a "high potential for abuse," states the drug’s label. The restricts the use of Cesamet prescriptions to the amount necessary for a single cycle of chemotherapy (i.e., a few days). It is also not intended as a first-line treatment for chemo-related nausea and vomiting. 

The guideline also say the prescribers should monitor patients for signs of excessive use, abuse, and misuse. 

The American Cancer Society estimates that there will be nearly 1.4 million new cancer cases in 2006. Approximately 70 to 80 percent of all patients receiving chemotherapy experience chemotherapy-induced nausea and vomiting (CINV). Although the use of anti-emetic agents decreases the incidence and severity of CINV, symptoms continue to occur in 40 to 60 percent of patients.




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