Federal regulators are reviewing an application from the British makers of a medical marijuana mouth spray – Sativex – as a potential treatment for cancer pain.
GW Pharmaceuticals said the U.S. Food and Drug Administration has accepted its application to market the spray in the United States in coming years. The spray, which company officials said has little potential for abuse, is being testing for effectiveness in clinical trials that could be completed as early as 2014.
Sativex contains tetrahydrocannabinol (THC), the active ingredient in marijuana, according to a company news release. In approving GW’s application, the FDA is allowing the company to conduct clinical trials involving 250 American cancer patients, officials said.
The trials aim to determine if the drug can relieve pain, reduce the use of other medications, improve sleep and other quality-of-life issues, GW said in its release. The drug is already approved for use in Canada, England and other countries.
Pain is a common symptom in cancer patients. Prior studies of the GW drug have proven it to be effective, the company said.
"Sativex seems to be a very promising treatment option for patients whose pain does not respond to current analgesics," said Dr. Nathaniel Katz, of Tufts University School of Medicine, in the GW release. "The clinical data thus far suggest that many patients who have been suffering with intractable pain may gain significant benefit from the use of Sativex.”