New York, NY: Forty medical centers across North America will take part in the first-ever US clinical trial assessing the efficacy of Sativex, an oral spray consisting of natural cannabis extracts, for the treatment of advanced cancer pain.
More than 300 patients with advanced-stage cancer will be recruited for the five-week trial, which will assess the use of Sativex as an adjunct treatment for patients with intractable cancer pain. Subjects in the trial must have a clinical diagnosis of cancer-related pain and must be unresponsive to opioid-based analgesics.
Investigators in the study will be using an 11-point Numeric Rating Scale to determine whether patients’ reported pain scores have fallen by the completion of the trial.
Russel K. Portenoy, chief investigator of the study and Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City, said: “[M]ore than one-third of patients with cancer, and more than three-quarters of those with advanced disease, have chronic pain. Large surveys indicate that optimal opioid therapy does not yield sufficient relief in a substantial proportion of these patients. There is a clear need for new treatments to improve these outcomes and it is our hope that cannabinoid formulations may represent an important option in the future.”
In previous clinical trials of the drug, cancer patients have reported significantly improved pain relief following Sativex administration. Earlier this month, investigators in Britain reported that long-term administration of Sativex reduces neuropathic pain without inducing tolerance in patients with multiple sclerosis (MS).
Canadian health officials granted regulatory approval in August for the prescription use of Sativex to treat cancer pain. Sativex had previously gained regulatory approval in Canada for the treatment of MS-associated neuropathic pain. Regulators in Great Britain and Spain have also granted limited regulatory approval for the drug.
The makers of Sativex, British-based biotechnology firm GW Pharmaceuticals, told Bloomberg News that they expect to have results from the trial next year and are hopeful that they will receive US regulatory approval for the drug by 2011.
For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at: paul@norml.org, or visit http://www.gwpharm.com.