Nabiximols, marketed as Sativex, is a cannabis derived pharmaceutical spray developed by GW Pharmaceuticals. Each dose combines two active cannabinoids, tetrahydrocannabinol and cannabidiol, delivering about 2.7 milligrams of THC and 2.5 milligrams of CBD. The spray was approved as a botanical drug in the United Kingdom in 2010 and is intended to treat symptoms of multiple sclerosis such as neuropathic pain, spasticity, and an overactive bladder. It has since been approved in other countries for these multiple sclerosis symptoms, and in Canada for additional uses including neuropathic pain and cancer pain.
Facts
Drug ClassCannabis-derived analgesic, ATC code N02BG10 1 Mechanism of ActionTHC acts as a partial agonist at CB1 and CB2 cannabinoid receptors, modulating neurotransmitter effects 1 Approved UseTreats moderate to severe MS spasticity not adequately relieved by other anti-spasticity medication 1 First Approved / Isolated Year Significant RiskCommon adverse effects include dizziness, drowsiness and disorientation, with some patients discontinuing over side effects 4 Classification
Approval Status ATC ClassSourced to the subject's own account Route of Administration Route of Administration Connections
Sources
1. Sativex Summary of Product Characteristics (emc)
Pharmacodynamic properties section
Other Analgesics and Antipyretics, ATC code: N02BG10
Therapeutic indications section
Sativex is indicated as treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Pharmacodynamic properties section [mechanism-of-action]
THC acts as a partial agonist at both CB1 and CB2 receptors, mimicking the effects of the endocannabinoids, which may modulate the effects of neurotransmitters (e.g. reduce effects of excitatory neurotransmitters such as glutamate).
- Regulatory approval status
View the Source2. Anatomical Therapeutic Chemical Classification System (Wikipedia)
WikipediaFirst-level anatomical group codes, Code NQuote, First-level anatomical group codes, Code N
Nervous system
3. Nabiximols (Wikipedia)
WikipediaInfobox drug, routes_of_administrationQuote, Infobox drug, routes_of_administration
Oromucosal spray
4. Nabiximols (Wikipedia)
Availability section
In June 2010, the Medicines and Healthcare products Regulatory Agency of the United Kingdom licensed nabiximols as a prescription-only medicine
Side effects section
The most common adverse effects in Phase III trials were dizziness (25%), drowsiness (8%) and disorientation (4%); 12% of subjects stopped taking the drug because of the side effects.
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