Valeant receives approval for ‘synthetic cannabis’ drug

Valeant, the speciality pharmaceuticals company, has announced it has received FDA approval for its cannabinoid drug, Cesamet.

Cesamet, known as Nabilone in some countries, contains an active ingredient chemically related to cannabis. It will be used to treat nausea and vomiting in patients undergoing cancer chemotherapy if they have not responded well to typical anti-emetics.

Valeant bought Cesamet from Eli Lilly in 2004 and it is sold in Canada, where it has an 86 per cent share of the cannbinoid market, according to the company.

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

Neal Slatkin, director at the department of supportive care, pain and palliative medicine at City of Hope National Medical Centre, added: “Chemotherapy-induced nausea and vomiting dramatically impacts cancer patients’ quality of life and can result in patients refusing courses of chemotherapy, which minimizes chances for the best possible outcome.”

Valeant says that almost all of the patients involved in clinical trials experienced some for of adverse side-effects, including drowsiness, vertigo, euphoria (or feeling “high”), headaches and difficulty concentrating. It recommends that Cesamet users do not drive when taking the medication.

Cesamet is already available in the UK for use in chemotherapy patients suffering from nausea and vomiting. According to the British Medical Association, change in international law has permitted the prescription of dronabinol, another cannabinoid used for the similar purposes, although it is not licensed and must be imported specially on a “named patient basis”.

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