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Oromucosal as an Alternative Method for Administration of Cannabis Products in Rodents
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Sativex(®) (tetrahydrocannabinol + cannabidiol), an endocannabinoid system modulator: basic features and main
1Centre Hospitalier Régional Universitaire de Lille, Lille, France. patrick.vermersch@chru-lille.fr.
Expert Review of Neurotherapeutics
|April 1, 2011
Summary
Sativex (nabiximols) effectively reduced multiple sclerosis (MS) spasticity in clinical trials, offering a new symptomatic treatment option. This cannabis-based medicine showed significant improvements in spasticity scores and quality of life for MS patients.
Area of Science:
- Neuroscience
- Pharmacology
- Clinical Medicine
Background:
- Multiple sclerosis (MS) is a chronic neurological disease characterized by spasticity, a significant symptom impacting patient quality of life.
- Existing disease-modifying agents for MS primarily target underlying pathophysiology, with a continued need for effective symptomatic treatments, particularly for spasticity and pain.
- Sativex (nabiximols) is an oromucosal spray derived from Cannabis sativa, containing tetrahydrocannabinol and cannabidiol in a 1:1 ratio, acting as an endocannabinoid system modulator.
Purpose of the Study:
- To evaluate the efficacy and safety of Sativex (nabiximols) as an add-on therapy for managing treatment-resistant spasticity in patients with multiple sclerosis.
- To assess the impact of Sativex on spasticity scores, quality of life, and adverse events in a large patient cohort.
Main Methods:
- Conducted multiple randomized, controlled clinical trials involving over 1500 patients with MS-related resistant spasticity.
- Utilized a 0-10 numerical rating scale (NRS) for spasticity as the primary endpoint.
- Employed varying study durations (6, 15, and 12 weeks in placebo-controlled phases) and patient populations, including initial responders and a general patient group.
Main Results:
- Sativex demonstrated a statistically significant reduction in NRS spasticity scores compared to placebo in pivotal trials (e.g., -1.18 vs -0.63, p=0.048; -1.3 vs -0.8, p=0.035).
- A sustained efficacy was observed, with initial responders showing further improvement on Sativex compared to a decrease on placebo (0.04 vs -0.81, p=0.0002).
- Significant improvements in quality-of-life measures were reported, with common adverse events being mild and transient (dizziness, fatigue, somnolence).
Conclusions:
- Sativex (nabiximols) oromucosal spray is an effective and well-tolerated option for managing resistant spasticity in multiple sclerosis patients.
- The treatment does not appear to cause tolerance, withdrawal, misuse, or abuse, and lacks the adverse effects associated with recreational cannabis.
- Sativex addresses an unmet need for symptomatic relief in MS management, complementing existing disease-modifying therapies.
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