Cesamet™ Approved for Nausea and Vomiting Associated with Cancer Treatment

Cesamet™ Approved for Nausea and Vomiting Associated with Cancer Treatment

The U.S. Food and Drug Administration (FDA) has recently approved the agent Cesamet (nabilone) for the treatment of nausea and vomiting in cancer patients undergoing therapy who have not responded to standard treatment for nausea and vomiting.

Severe nausea and vomiting is an often distressing side effect of chemotherapy. Despite significant progress over the past decade in managing chemotherapy-induced nausea and vomiting (CINV), more than half of all patients receiving chemotherapy still suffer from these side effects. Symptoms can be severely debilitating and often lead patients to refuse further courses of chemotherapy; this minimizes chances for an optimal outcome.

Different chemotherapy agents and/or chemotherapy combinations are associated with inducing nausea and vomiting to varying degrees; some chemotherapy agents are highly associated with nausea and vomiting, while others are moderately or rarely associated with this side effect. Fortunately, drugs to prevent nausea and vomiting (antiemetic drugs) can be given to patients before and during chemotherapy.

Some patients do not respond to standard antiemetic therapy. These patients have had limited relief with their nausea and vomiting.

Cesamet is an oral agent that interacts with CB1, a cannabinoid receptor found throughout the nervous system. It is involved in regulating nausea and vomiting. Cesamet is a synthetic version of the active agent in marijuana.

Results from clinical trials comparing cesamet to other standard antiemetic agents or placebo (inactive substitute) have demonstrated its effectiveness in reducing nausea and vomiting among patients who do not respond to standard antiemetic therapies.

Researchers warn, however, that Cesamet should be used with caution among patients known to have addiction issues.

Reference: Valeant Pharmaceuticals International. Valeant Pharmaceuticals Receives FDA Marketing Approval for Cannabinoid Cesamet(TM) (CII). Available at: http://www.valeant.com/mediaCenter/newsArticle/newsArticle.jspf;jsessionid =CF529997CDFD34398E88F25855823E24.frank?objectId=4158. Accessed May 2006.

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