Nabiximols

Nabiximols
INN: Tetrahydrocannabinol Botanical Drug Substance [1]
Chemical structures of tetrahydrocannabinol (top) and cannabidiol (bottom)
Combination of
TetrahydrocannabinolCannabinoid
CannabidiolCannabinoid
Clinical data
Trade namesSativex
Routes of
administration
Oromucosal spray
ATC code
Legal status
Legal status
  • AU: S8 (Controlled drug)
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
PubChem CID
UNII
CompTox Dashboard (EPA)
 ☒NcheckY (what is this?)  (verify)
Canadian packaging of a case of Sativex vials

Nabiximols (USAN)[2] sold under the brand name Sativex, is a specific Cannabis extract that was approved in 2010 as a botanical drug in the United Kingdom. Nabiximols is sold as a mouth spray intended to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms of multiple sclerosis; it was developed by the UK company GW Pharmaceuticals.[3][4] In 2019, it was proposed that following application of the spray, nabiximols is washed away from the oral mucosa by the saliva flow and ingested into the stomach, with subsequent absorption from the gastro-intestinal tract.[5][6] Nabiximols is a combination drug standardized in composition, formulation, and dose. Its principal active components are the cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD). Each spray delivers a dose of 2.7 mg THC and 2.5 mg CBD.

In 2003, GW Pharmaceuticals partnered with Bayer to market the drug under the brand name Sativex. In 2011, GW licensed the rights to commercialise nabiximols to Novartis for Asia (excluding China and Japan), Africa and the Middle East (excluding Israel).[7]

  1. ^ "DDrare: Database of Drug Development for Rare Diseases". ホーム | DDrare (in Japanese). 2016-12-28. Retrieved 2024-03-23.
  2. ^ "Statement on a non-proprietary name" (PDF). United States Adopted Names Council.
  3. ^ "Nabiximols". UK Medicines Online.[permanent dead link] Page accessed Feb 3, 2016
  4. ^ "Sativex (nabiximols) - factsheet". Multiple Sclerosis Trust. October 2014.
  5. ^ Itin C, Barasch D, Domb AJ, Hoffman A (May 2020). "Prolonged oral transmucosal delivery of highly lipophilic drug cannabidiol". International Journal of Pharmaceutics. 581: 119276. doi:10.1016/j.ijpharm.2020.119276. PMID 32243971. S2CID 214785913.
  6. ^ Itin C, Domb AJ, Hoffman A (October 2019). "A meta-opinion: cannabinoids delivered to oral mucosa by a spray for systemic absorption are rather ingested into gastro-intestinal tract: the influences of fed / fasting states". Expert Opinion on Drug Delivery. 16 (10): 1031–1035. doi:10.1080/17425247.2019.1653852. PMID 31393180. S2CID 199505274.
  7. ^ "GW signs Sativex cannabis-based drug deal with Novartis". The Telegraph. 11 April 2011. Retrieved 12 July 2012.