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Administration of Δ9-Tetrahydrocannabinol (THC) in Adolescent and Adult Mice
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THC:CBD spray and MS spasticity symptoms: data from latest studies
1Bergen Hospital and University of Bergen, Bergen, Norway.
European Neurology
|January 25, 2014
Summary
New clinical data on 9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) oromucosal spray show it is safe and effective for MS spasticity. Long-term use did not cause cognitive decline or mood changes, supporting its benefit-risk profile.
Area of Science:
- Neuroscience
- Pharmacology
- Clinical Medicine
Background:
- Multiple Sclerosis (MS) spasticity presents significant challenges for patients.
- Existing treatments for MS spasticity have limitations.
- 9-delta-tetrahydrocannabinol (THC) and cannabidiol (CBD) oromucosal spray offers a potential therapeutic option.
Purpose of the Study:
- To review new clinical experience with THC:CBD oromucosal spray in MS spasticity.
- To assess the long-term safety and efficacy of THC:CBD spray.
- To evaluate the impact of THC:CBD spray on cognitive function, mood, and driving ability.
Main Methods:
- Review of post-marketing surveillance studies and patient registries (UK, Germany, Spain).
- Analysis of a randomized, placebo-controlled long-term follow-up clinical trial.
- Prospective observational pilot study assessing driving ability.
Main Results:
- Over 1,000 additional patients' data reviewed, reinforcing Phase III findings.
- 12-month trial showed no cognitive decline, depression, or mood changes.
- Observational study indicated no adverse impact on driving ability.
- Real-world usage showed lower average dosages than clinical studies, with maintained effectiveness.
- No new safety concerns identified in long-term registry data (up to 2 years exposure).
Conclusions:
- THC:CBD oromucosal spray demonstrates a positive benefit-risk relationship for longer-term use in MS spasticity.
- The spray is associated with maintained efficacy and safety in clinical practice.
- Further supports the use of THC:CBD spray as a treatment option for MS spasticity.
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