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FDA approves Valeant’s chemo-induced nausea drug

The FDA has given marketing approval for Valeant Pharmaceuticals' Cesamet oral capsules to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.

Cesamet is a synthetic version of cannabis that is thought to interact with the cannabinoid receptor, CB1, which is present throughout the nervous system and is involved in regulating nausea and vomiting.

According to the company, this mechanism of action for Cesamet is significantly different from conventional anti-emetics.

One of the benefits of Cesamet is a long duration of action, which allows for less frequent dosing, typically twice daily.

“There is still a significant unmet need in treating one of the most feared and severe consequences of life-saving cancer therapies,” said Timothy Tyson, Valeant's president and CEO. “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.”

Valeant acquired Cesamet from Eli Lilly in 2004 and currently sells the drug in Canada, where the product has an 86% share of the cannabinoid market, according to sources cited by the company.