OK from the FDA for synthetic marijuana drug

May 17 2006

Despite saying quite recently that it does not support the use of marijuana for medical purposes, the U.S. Food and Drug Administration (FDA) has given marketing approval for a drug which is a synthetic version of the active ingredient in marijuana.

The drug Cesamet is intended for use in treating the nausea and vomiting resulting from cancer chemotherapy and in particular for those patients who have failed to respond to conventional anti-emetic treatments.

The approval comes seventeen years after the drug was withdrawn from U.S. markets.

Cesamet is a synthetic cannabinoid that is thought to work by interacting with the cannabinoid receptor, CB1, which is present throughout the nervous system and regulates nausea and vomiting.

Cesamet is significantly different from conventional anti-emetics and has a long duration of action, which allows for less frequent dosing, typically twice daily.

It is a Schedule II drug, indicating a high potential for abuse.

The 1-milligram tablets are meant to be taken twice daily before cancer patients undergo chemotherapy and up to 48 hours following treatment.

The side effects can include euphoria, drowsiness, vertigo and dry mouth.

Valeant Pharmaceuticals International who manufacture Cesamet hope the drug will be on sale shortly.

Cesamet is already on sale in Canada under the name Nabilone.

The drug will be in competition with Marinol, made by Belgium company Solvay. Marinol is synthetic version of tetrahydrocannabinol, the active ingredient in marijuana which is more commonly known as THC.

The American Cancer Society estimates that there will be nearly 1.4 million new cancer cases in 2006.

Approximately 70 to 80 percent of patients receiving chemotherapy experience stomach upset and a strong urge to vomit and though the use of anti-emetic agents decreases the incidence and severity of the symptoms, they continue to occur in 40 to 60 percent of patients.