Commenting on the recommendation, Dr Sajida Javaid, Consultant in Rehabilitation Medicine, Neath Port Talbot Hospital said, “The AWMSG’s recognition of the value of Sativex is a significant milestone for the treatment of spasticity. Improved access to Sativex has been long awaited by clinicians and patients since its launch in 2010, so it is encouraging to see that patients in Wales will now have improved access to a treatment that has been proven to provide significant relief from the spasms and cramps associated with spasticity.”
The recommendation from the AWMSG states: Delta-9-tetrahydrocannabinol/cannabidiol (Sativex) is recommended as an option for use within NHS Wales as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Sativex is only available on prescription from a physician with experience in treating MS spasticity. It should be sprayed on to different sites of the oromucosal surface, changing the application site each time it is used. The MS patient decides how many sprays they need in any one day with a typical patient taking four sprays a day (daily limit of up to 12 sprays).
In the phase III clinical trial, Sativex was shown to provide significant improvement in the 0-10 numeric rating scale (NRS) spasticity score and spasm frequency, compared with placebo. After a four-week, single-blind therapeutic trial period in 572 patients, Sativex reduced a mean spasticity 0-10 NRS score by 3.01 points, from a baseline of 6.91 points.4 48% of patients achieved a ≥20% improvement in mean spasticity 0-10 NRS during this initial period. Of these responders, 241 proceeded into a 12-week, randomised, placebo-controlled trial phase. At the end of the trial, Sativex had reduced the mean spasticity 0-10 NRS in responders by significantly more than placebo (estimated treatment difference 0.84 points; p=0.0002). The percentage of patients achieving a clinically relevant response during the randomised phase of the trial (≥30% improvement in mean spasticity 0-10 NRS from baseline), was significantly greater in the Sativex® group than the placebo group (74% vs. 51%; p=0.0003).
The most common side effects of Sativex are dizziness, which occurs mainly in the first few weeks of treatment, and fatigue. These reactions are usually mild to moderate and improve within a few days even if treatment is continued.