The American Cancer Society estimates that about 1.4 million Americans will be diagnosed with cancer in 2006. Many cancer patients experience nausea and vomiting associated with chemotherapy. The marijuana drug Cesamet treats nausea and vomiting associated with chemotherapy in cancer patients who don't effectively respond to conventional anti-nausea treatments. In 1985 the FDA first approved Cesamet, made by Eli Lilly and Company, but the drug was discontinued in 1989. Valeant Pharmaceuticals International bought Cesamet from Lily in 2004. Now the Food and Drug Administration (FDA) has approved the release of Valeant's Cesamet.
"There is still a significant unmet need in treating one of the most feared and severe consequences of life-saving cancer therapies," says Timothy C. Tyson, Valeant's president and chief executive officer, in a news release. "With the approval of Cesamet, Valeant is proud to offer a solution that will help alleviate one of the most common side effects of chemotherapy."
Cesamet contains synthetic cannabinoid, the active ingredient in marijuana. The drug interacts with cannabinoid receptors (CB1) in the brain, which regulate nausea and vomiting. Eleven clinical trials tested Cesamet's safety and effectiveness with over 300 patients, five trials compared Cesamet with an anti-nausea drug Compazine (prochlorperazine), and six studies compared Cesamet with a placebo (no medication). All of the studies but one favored Cesamet for relieving vomiting and nausea most effectively.
Valeant warns that Cesamet has a high potential for abuse, since it contains an active ingredient similar to marijuana. Therefore, Cesamet should be used with caution in patients with a history of substance abuse. Cesamet should also be used with caution in pregnant women, nursing mothers, children, and the elderly, as well as patients with psychiatric disorders (including manic depressive illness, depression and schizophrenia), hypertension or heart disease.
Valeant states that all of the patients in the Cesamet trials experienced at least one adverse effect. The most common side effects were euphoria, dry mouth, drowsiness, and vertigo.
REFERENCES:
1.Valeant Pharmaceuticals Receives FDA Marketing Approval For Cannabinoid Cesamet (TM) (CII), Valeant Pharmaceuticals International, News Release, May 16, 2006: http://www.valeant.com/mediaCenter/newsArticle/newsArticle.jspf?objectId=4158
2. Hitti M. FDA OKs Return of Marijuana Drug. WebMD, May 18, 2006:
http://www.webmd.com/content/article/122/114698.htm
Posted by Elaine Gavalas on August 17, 2006 02:18 PM
