London, United Kingdom: The administration of Sativex, an oral spray consisting of natural cannabis extracts, significantly improves spasticity in Multiple Sclerosis (MS) patients who have failed to respond to currently available anti-spasticity treatments, according to the preliminary results of clinical trial data announced last week by the British technology firm GW Pharmaceuticals.
Three hundred and thirty five patients with MS-associated spasticity participated in the 14-week randomized, placebo-controlled trial. "Analysis of the per protocol population (those patients that complied with the study protocol) showed positive and statistically significant improvement ... in spasticity as measured on a 1-10 numeric rating scale," the company stated in a press release. "All patients entering the study were taking the best available anti-spasticity medication and remained on such medication through the trial. ... [I]mprovements seen in the trial were obtained over and above currently available treatment."
Patients in the trial who did not comply with the study's protocol also gained relief from Sativex, though not to a degree that reached statistical significance. Investigators attributed this result to a larger than expected placebo-response, thus reducing the size of the difference between the experimental and control groups.
The company also announced that a separate analysis of the three clinical trials now completed on Sativex and MS-associated spasticity, incorporating a total of 652 patients, shows the spray to be significantly superior to placebo.
Earlier this year, United States regulatory officials authorized the first-ever clinical trial in the US investigating the efficacy of Sativex 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.
Two additional Phase III clinical trials investigating the use of Sativex on peripheral neuropathic pain are scheduled to be completed later this year.
For more information, please contact Paul Armentano, NORML Senior Policy Analyst, at (202) 483-5500 or visit: http://www.gwpharm.com.