Rockville, MD: The US Food and Drug Administration (FDA) this week re-approved a synthetic cannabinoid analogue for prescription use in the United States.
The oral pill, marketed as Cesamet (also known as naboline), is an analogue (a structural derivative) of the cannabinoid THC. It will be available as a Schedule II controlled substance for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional anti-emetic treatments.
Marinol (dronabinol), the only synthetic cannabinoid legally available on the US market, is classified as a Schedule III drug under federal law.
Although Cesamet was initially approved by the FDA in 1985, it was later withdrawn from the market by then-manufacturer Eli Lilly for commercial reasons. The drug has been marketed as an anti-nauseant in Canada and the United Kingdom by Valeant Pharmaceuticals, which purchased the rights to Cesamet in 2004. According to the manufacturer, potential adverse reactions to the drug include ataxia (loss of ability to coordinate muscular movement), euphoria, headache, vertigo, increased heart rate, and concentration difficulties.
Cesamet will be available in 1-milligram tablets, meant to be taken twice daily. Marinol (synthetic THC in sesame oil) is available in 2.5mg, 5mg and/or 10mg dosages.
Though legally available in the US, few patients report positive experiences with Marinol because of its high price tag, delayed onset, and heightened psychoactivity.
Mallinckrodt pharmaceuticals is currently developing a generic version of Marinol for sale in the US market.
For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at (202) 483-5500. Additional information on Marinol and synthetic THC is available in NORML’s report: “Marinol vs Natural Cannabis: Pros, Cons, and Options for Patients,” online at: http://www.norml.org/index.cfm?Group_ID=6635