FDA approves Valeant's cannabinoid Cesamet for chemotherapy-induced nausea, vomiting

By Lisa Kerner

Erie, Pa., May 16 - The Food and Drug Administration has granted marketing approval to Valeant Pharmaceuticals International's Cesamet (CII) (nabilone) oral capsules used to treat nausea and vomiting associated with cancer chemotherapy.

Valeant, which acquired Cesamet from Eli Lilly & Co. in 2004, currently sells Cesamet in Canada. The company said it entered into an agreement with Par Pharmaceutical Cos. Inc. to promote Cesamet in the United States and expects to launch the product in the next several weeks.

The synthetic cannabinoid Cesamet acts as an omnineuromodulator, interacting with the cannabinoid receptor that helps regulate nausea and vomiting, making its method of action different from conventional anti-emetics.

Cesamet also has a long duration of action, allowing for less frequent dosing, typically twice daily.

Valeant said Cesamet has been evaluated in patients receiving a wide variety of chemotherapy regimens, including low-dose cisplatin in both placebo-controlled and active controlled (prochlorperazine) trials, with efficacy and safety results derived from 11 double-blind, crossover studies.

"There is still a significant unmet need in treating one of the most feared and severe consequences of life-saving cancer therapies," president and chief executive officer Timothy C. Tyson said in a news release.

About 70% to 80% of all patients receiving chemotherapy experience chemotherapy-induced nausea and vomiting.

Valeant is a Costa Mesa, Calif., specialty pharmaceutical company that develops, manufactures and markets products primarily in the areas of neurology, infectious disease and dermatology.

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