Salisbury, United Kingdom: Medicinal cannabis extracts significantly reduce pain in cancer patients compared to placebo, according to the results of clinical trial data announced this week by Britain's GW Pharmaceuticals.
One hundred and seventy-seven patients with advanced cancer participated in the double-blind, randomized, placebo-controlled trial. Patients in the trial suffered from chronic pain and were unresponsive to standard analgesic therapies. Volunteers were administered either Sativex (an oral spray containing precise doses of the cannabinoids THC and CBD), a THC-only extract, or placebo. All of the patients in the study remained on their existing analgesic medications during the trial.
"Sativex achieved a statistically significant improvement in comparison to placebo in pain," the company announced in a prepared statement. "A responder analysis showed that approximately 40 percent of patients on Sativex showed greater than 30 percent improvement in their pain."
Patients administered extracts containing primarily THC did not experience a significant alleviation in pain.
Commenting on the results of the study, GW Pharmaceuticals spokesperson Stephen Wright said: "Patients in this trial were suffering intense pain as a result of their cancer despite using currently available strong opioid treatments and therefore have a very high clinical need. The data from this important trial further demonstrates the broad potential of Sativex, not only in its initial Multiple Sclerosis and neuropathic pain markets, but also in cancer and potentially other types of chronic pain. These positive results suggest that Sativex may represent a valuable new treatment option for this group of patients."
In December, Health Canada issued a "Qualifying Notice" for the approval of Sativex for the treatment of neuropathic pain associated with Multiple Sclerosis. However, British regulatory approval for the drug was delayed after an advisory body of the British Medicines and Health products Regulatory Agency (MHRA) announced late last year that it required further clinical evidence of Sativex's ability to alleviate MS-associated spasticity in a "clinically relevant" manner.
The company is also initiating plans to seek regulatory approval for the prescription use of Sativex in the United States, Reuters News Service reported.