Valeant Pharmaceuticals has won marketing approval in the USA for Cesamet, a drug to treat nausea and vomiting associated with cancer chemotherapy, 17 years after it was taken off the market.
The company received an approvable letter from the US Food and Drug Administration for Cesamet (nabilone) at the end of 2005, after the agency asked for additional information on adverse events.
Cesamet is a synthetic cannabinoid similar to the active ingredient found in marijuana, has been cleared for use in cancer patients who haven't responded adequately to conventional anti-emetic treatments, including prochlorperazine and newer agents such as GlaxoSmithKline’s Zofran (ondansetron) and Roche's Kytril (granisetron).
Lilly originally won approval for Cesamet in 1985, but withdrew it from the market in 1989 for 'commercial reasons'.
Approximately 70%-80% of all patients receiving chemotherapy experience chemotherapy-induced nausea and vomiting (CINV), and symptoms persist in 40%-60% of patients, despite treatment. Valeant says the new drug works differently from all available anti-emetics.
The company said the product has a long duration of action, which allows for less frequent dosing, usually twice a day. It will compete in the USA with another synthetic cannabinoid, Marinol, sold by Solvay.
Valeant acquired Cesamet from Eli Lilly in 2004 and already sells the product in Canada, where it has about an 86% share of the cannabinoid market, accoridng to IMS data. It expects to launch Cesamet in the USA within the next few weeks.
Last year, the company reached agreement with Par Pharmaceutical to promote the product in the USA.