Flachenecker P, Henze T, Zettl UK.Nabiximols (THC/CBD Oromucosal Spray, Sativex®) in Clinical Practice – Results of a Multicenter, Non-Interventional Study (MOVE 2) in Patients with Multiple Sclerosis Spasticity. Eur Neurol. 2014 Feb;71(5-6):173-181. [Epub ahead of print]
Background: Nabiximols (Sativex®), a cannabinoid-based oromucosal spray, is an add-on therapy for patients with moderate to severe multiple sclerosis spasticity (MSS) resistant to other medications. The primary objective was to provide real-life observational data of clinical experience of nabiximols in contrast to formal clinical trials of effectiveness.
Methods: This was an observational, prospective, multicenter, non-interventional study with a follow-up period of 3-4 months, conducted in routine care setting in Germany. Patients with moderate to severe MSS were included at nabiximols’ initiation. Structured documentation forms, questionnaires and validated instruments were used for data collection at inclusion, 1 and 3 months after inclusion.
Results: Overall, 335 patients were assessed of whom 276 fitted the criteria and were included in the effectiveness analysis. After 1 month, nabiximols provided relief of resistant MSS in 74.6% of patients according to specialist assessment; mean spasticity 0-10 numerical rating scale (NRS) score decreased from 6.1 ± 1.8 to 5.2 ± 2.0 points; in patients with NRS improvement ≥20% mean NRS score decreased by 40%. After 3 months, 55.3% of patients had continued to use nabiximols and the mean NRS score had decreased by 25% from baseline. 17% of patients reported adverse events.
Conclusion: Real-life data confirm nabiximols as an effective and well-tolerated treatment option for resistant MSS in clinical practice.
Sativex can alleviate spasticity, unfortunately this is not going to make NICE change its mind. The problem in the UK is the price does not seem to be right……Too high… and that’s just the price.
That there was about a twenty percent drop by three months of use compared to one month, suggests either the result did not justify the cost, the taste was so unpleasant that it did not justify the use. The cannabis is dissolved in alcohol and so it essentially fixes your cheek when you spray under the tongue. This must be unpleasant as in the trials where the placebo group could go up to 24 puffs a day they never did and stuck at about a half of this max. However if you are a user what’s your experience. Lastly the people may have stopped using it because they just did not like the high.
The biology dictates that it is not possible to completely dissociate the effects from the side-effects, but there may be a narrow window of opportunity to see some benefit. There was some but it was not a massive effect.
CoI: TeamG are developing an alternative to Sativex, now in Man!