Nabiximols

Availability and Approval:

• Nabiximols (Sativex) is approved in the UK for spasticity due to multiple sclerosis.
• Funded by NHS in Wales for people with multiple sclerosis.
• Approved in Spain, Czech Republic, Germany, Denmark, and Sweden for MS spasticity.
• Recommended for approval in Italy and Austria.
• Available in Canada for MS spasticity, neuropathic pain, and cancer pain.

Effectiveness:

• Showed reduction in spasticity in Phase III studies.
• Meta-analysis in 2009 showed variations in effectiveness.
• American Academy of Neurology review in 2014 found effectiveness for spasticity, pain, and urinary dysfunction.
• 2021 study showed clinically relevant results.
• Studied for cancer pain with mixed efficacy results.

Side Effects and Safety:

• Generally well tolerated in early clinical trials.
• Common adverse effects include dizziness, drowsiness, and disorientation.
• 12% of subjects stopped taking due to side effects.
• No evidence of negative effects on cognitive ability.
• Potential for dependence is unlikely.

Licensing and Regulatory Status:

• GW Pharmaceuticals licensed to cultivate cannabis for Sativex in the UK.
• Sole legal right to research in aerosolized cannabis-derived therapeutics.
• Commercially viable in the UK since April 2013.
• Sativex formulation scheduled under the UK Drugs Act.
• Sativex has been moved to Schedule 4 of the UK Drugs Act.

Future Research and Development:

• Ongoing research aims to explore the potential benefits of Sativex in various medical conditions.
• Future studies may focus on optimizing the dosing and administration of Sativex.
• Investigating the mechanisms of action of Sativex is crucial for future drug development.
• Collaborative research is essential for advancing the clinical applications of Sativex and similar cannabinoid medicines.
• Research efforts are directed towards understanding the broader therapeutic potential of cannabinoid medicines.

Nabiximols Data Sources