The US FDA has given marketing approval for Cesamet (CII) (nabilone) oral capsules of Valeant Pharmaceuticals International. Cesamet is used to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.
"There is still a significant unmet need in treating one of the most feared and severe consequences of life-saving cancer therapies," Timothy C. Tyson, Valeant's president and chief executive officer said adding, "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 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 Cesamet is significantly different from conventional anti-emetics. Cesamet has a long duration of action, which allows for less frequent dosing, typically twice daily.
Valeant acquired Cesamet from Eli Lilly & Company in 2004 and currently sells Cesamet in Canada, where the product has an 86 per cent share of the cannabinoid market, according to IMS Compuscript data from February 2006. Last year, Valeant entered into an agreement with Par Pharmaceutical Companies, Inc. to promote Cesamet in the United States. Valeant anticipates launch of Cesamet in the next several weeks following approval.
"In my practice, Cesamet has been used successfully to treat patients with chemotherapy-induced nausea and vomiting," said Paul Daeninck, assistant professor, Department of Oncology at the University of Manitoba in Winnipeg, Canada. "We have found that it offers long-acting chemotherapy-induced nausea and vomiting relief in a well-tolerated and convenient twice-a-day regimen," he added.
The American Cancer Society estimates that there will be nearly 1.4 million new cancer cases in 2006. Approximately 70 to 80 per cent 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 per cent of patients.