Rockville, MD: United States regulatory officials last week authorized the first-ever US clinical trial investigating the efficacy of Sativex, an oral spray consisting of natural cannabis extracts, for the treatment of cancer pain. Sativex is currently available by prescription in Canada and on a limited basis in Spain and Great Britain for patients suffering from neuropathic pain, Multiple Sclerosis (MS), and other conditions.
The FDA-approved trial is expected to begin later this year and will likely take 24 to 36 months to complete. Two hundred and fifty patients with advanced cancer will participate in the randomized, placebo-controlled study, which will evaluate the effect of Sativex in relieving patients’ average daily pain, reducing their use of opioid medications, and improving their overall quality of life.
In a previous clinical trial of 177 cancer pain patients, volunteers administered Sativex demonstrated statistically significant improvements in comparison to placebo, with 40 percent of patients showing greater than 30 percent improvement in pain. Patients in the trial had previously been unresponsive to standard analgesic medicines (e.g., morphine).
Other clinical trials of Sativex have demonstrated the drug to alleviate numerous MS-associated symptoms compared to placebo, including pain, muscle spasms, and bladder incontinence.
British biotechnology company GW Pharmaceuticals, makers of Sativex, stated that the FDA’s decision allowing them to move directly to Phase III testing of the drug hastens their timeline for gaining US market approval for Sativex.
“GW believes that Sativex represents a first-in-class valuable new treatment option for the many advanced cancer patients in the United States whose suffering has not been adequately managed by current opioid pain medications,” the company said in a press release.
For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at (202) 483-5500 or visit: http://www.gwpharm.com