Two post-approval randomized trials confirmed that THC:CBD oromucosal spray (Sativex) effectively treats resistant MS spasticity without cognitive or mood effects after 50 weeks.
Neurologists, MS patients with treatment-resistant spasticity, and regulators evaluating cannabinoid medications.
No cognitive effects at 50 weeks
What the researchers found
A Phase IV trial found no effect of THC:CBD spray on cognition and mood after 50 weeks of treatment. The SAVANT study showed add-on THC:CBD spray was significantly more effective than readjusting standard antispasticity medication alone.
Why it matters
Post-marketing studies provide real-world evidence that is often lacking at initial drug approval. These studies address the two most common concerns about long-term cannabinoid medication: cognitive impairment and whether it outperforms existing treatments.
The numbers in context
Phase IV study: 50 weeks of treatment with no cognitive or mood effects detected. SAVANT: THC:CBD spray was significantly superior to readjusted standard antispasticity therapy.
How the study worked
Review of two post-approval randomized trials: a double-blind Phase IV cognitive safety study and the SAVANT trial comparing add-on THC:CBD spray vs. optimized standard treatment.
What this study cannot tell us
Review summarizes two trials rather than conducting new analysis. Both trials used enrichment designs (pre-selecting responders). Long-term data beyond 50 weeks for cognitive effects not available.
How to read the evidence
Strong: post-approval randomized trials from a regulatory risk management plan.
When this study was published
Published in 2019.
The bigger picture
Sativex's post-marketing track record is among the strongest for any cannabinoid medicine, demonstrating that pharmaceutical cannabinoids can pass the same regulatory scrutiny as conventional drugs.
Questions still open
- Does the cognitive safety finding extend beyond 50 weeks? Could similar THC:CBD formulations benefit spasticity in other neurological conditions?
Common questions
Does Sativex affect thinking or mood?
Is Sativex better than adjusting existing MS medications?
Read the original research
Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials.
Neurodegenerative disease management, 9(2s), 9-13
Citation
Marková, Jolana. (2019). Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials.. Neurodegenerative disease management, 9(2s), 9-13. https://doi.org/10.2217/nmt-2018-0050
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