Sativex (Delta(9)-tetrahydrocannabinol, Cannabidol)
Sativex, Delta(9)-tetrahydrocannabinol, Cannabidol (TCH/CBD) is an oral antispasticity agent, indicated as add-on treatment, for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS). TCH/CBD is only to be used in patients with MS spasticity not fully relieved with current antispasticity therapy, who in addition, achieves an improvement in spasticity of >20% on a 0-10 patient reported numeric scale (NRS) after four weeks of treatment.
In an enriched-design multicenter study, all patients were allocated to a 4-week-treatment period in a single blind manner, being unaware that of all received active treatment. Those with a least 20 % reduction in mean NRS were eligible for entry a 12 week randomized, double-blind placebo-controlled trial. The mean spasticity score over the course of the 12 week treatment period was compared to mean NRS score during week 4 (baseline) and was highly significant p=0.0002 (NRS= 0.83). However, the Modified Ashworth scale was insignificant between groups.
The most commonly reported adverse reactions in the first weeks of exposure are dizziness and somnolence. However, psychiatric symptoms such as anxiety, distoriation, hallucinations, and transient psychotic reactions have occurred. Further, suicidal ideation after administration of TCH/CBD has been suspected.
Alterations in pulse rate and blood pressure have been observed following initial dose so caution during titration is necessary. Thus, TCH/CBD is not recommended in patients with cardiovascular disease.
IRF consider Sativex, Delta(9)-tetrahydrocannabinol, Cannabidol (TCH/CBD) does improve symptoms in patients with moderate to severe spasticity due to multiple scleroses who has not responded adequately to other anti-spasticity medication. However, it is of concern that results were only significant when using self reported test including the NRS score, and not significant using the modified Ashworth scale. Furthermore, daily treatment with TCH/CBD cost around 8 times as much for an average use of 8 sprays a day as compared to e.g. treatment with tizanidine 24 mg daily.
Sativex, Delta(9)-tetrahydrocannabinol, Cannabidol was marketed on June 27th, 2011. There is no general reimbursement.
The Institute for Rational Pharmacotherapy, June 24th, 2011.