Post-approval trials confirm THC:CBD spray is safe and effective for resistant MS spasticity
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.
Quick Facts
What This Study 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.
Key Numbers
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 They Did This
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.
Why This Research 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 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.
What This Study Doesn't 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.
Questions This Raises
- ?Does the cognitive safety finding extend beyond 50 weeks?
- ?Could similar THC:CBD formulations benefit spasticity in other neurological conditions?
Trust & Context
- Key Stat:
- No cognitive effects at 50 weeks
- Evidence Grade:
- Strong: post-approval randomized trials from a regulatory risk management plan.
- Study Age:
- Published in 2019.
- Original Title:
- Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials.
- Published In:
- Neurodegenerative disease management, 9(2s), 9-13 (2019)
- Authors:
- Marková, Jolana
- Database ID:
- RTHC-02157
Evidence Hierarchy
Summarizes existing research on a topic.
What do these levels mean? →Frequently Asked Questions
Does Sativex affect thinking or mood?
A 50-week Phase IV trial found no effect of THC:CBD spray on cognition or mood, addressing a common concern about long-term cannabinoid use.
Is Sativex better than adjusting existing MS medications?
Yes, the SAVANT trial found that adding Sativex was significantly more effective than optimizing standard antispasticity medications alone.
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Cite This Study
https://rethinkthc.com/research/RTHC-02157APA
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
MLA
Marková, Jolana. "Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials.." Neurodegenerative disease management, 2019. https://doi.org/10.2217/nmt-2018-0050
RethinkTHC
RethinkTHC Research Database. "Newest evidence for tetrahydrocannabinol:cannabidiol oromuco..." RTHC-02157. Retrieved from https://rethinkthc.com/research/markova-2019-newest-evidence-for-tetrahydrocannabinolcannabidiol
Access the Original Study
Study data sourced from PubMed, a service of the U.S. National Library of Medicine, National Institutes of Health.
This study breakdown was produced by the RethinkTHC research team. We analyze and report published research findings without making health recommendations. All interpretations are based solely on the published abstract and study data.