Nabiximols
| General Information | ||
|---|---|---|
| Surname | Nabiximols ( USAN ) | |
| other names |
|
|
| CAS number | 56575-23-6 | |
| PubChem | 44148067 | |
| ATC code | N02 BG10 | |
| Drug class | Painkiller | |
| Prescription requirement | ||
| Components | ||
| Surname | Cannabidiol | Tetrahydrocannabinol |
| Structural formula |  |
|
| Molecular formula | C 21 H 30 O 2 | C 21 H 30 O 2 |
| CAS number | 13956-29-1 | 1972-08-3 |
Nabiximols is a mixture of plant extracts from the leaves and flowers of the hemp plant ( Cannabis sativa L.) used as a medicinal substance .
Nabiximols each contain standardized levels of tetrahydrocannabinol (THC) and cannabidiol (CBD) and are subject to narcotics regulations. The extract is the active ingredient of a drug approved in Great Britain, Denmark, the Czech Republic and Germany to improve spastic symptoms in patients with multiple sclerosis as part of an additional treatment. In Canada, the approval includes the concomitant treatment of neuropathic pain in multiple sclerosis and the treatment of pain in cancer patients for whom opioid therapy is not effective. Further areas of application, especially the treatment of cancer pain, are currently in clinical testing.
development
Nabiximols was developed by GW Pharmaceuticals and consists of two thick extracts made from the leaves and flowers of Cannabis sativa by extracting them with liquid carbon dioxide . A CBD chemotype is used for the production of one extract and a THC chemotype from Cannabis sativa is used for the other extract . Nabiximols is adjusted to fixed levels of THC and cannabidiol by varying the amount of the two extracts.
The Nabiximols-containing finished drug Sativex is an oral spray that is sprayed onto the inside of the cheek, as THC is particularly well absorbed through the oral mucosa.
Sativex is approved in several European countries for the additional treatment of patients with multiple sclerosis to improve moderate to severe spastic symptoms. The prerequisite is that the patient has not responded adequately to another antispastic therapy and that the symptoms improve clinically as a result of the therapy with Sativex. Applicant GW Pharmaceuticals withdrew an initial application for approval in Great Britain, Denmark, Spain and the Netherlands at the beginning of 2007 after the approval authorities of the countries found the therapeutic efficacy of Sativex to be insufficiently proven. After renewed applications in Great Britain and Spain in 2009, approval was granted in Great Britain in June 2010, followed by approvals in the Czech Republic in April, in Germany in May and in Denmark in June 2011. In Germany, Sativex has been on the market since July 2011. This was preceded in May 2011 by the reclassification of cannabis extract as a non-marketable narcotic ( Annex I of the German Narcotics Act , BtMG) to the group of prescription narcotics ( Annex III of the BtMG; only as finished medicinal products).
Individual evidence
- ↑ Statement on a Nonproprietary Name adopted by the USAN Council ( Memento from January 12, 2013 on WebCite )
- ^ Health Canada: Fact Sheet Sativex, April 2005.
- ^ Health Canada: Fact Sheet Sativex, August 2007.
- ↑ Entries in the ClinicalTrials.gov study register , as of January 1, 2011.
- ↑ a b Sativex: Report for the public by the British approval authority MHRA (English; PDF file; 479 kB)
- ↑ Sativex Oromucosal Spray: Summary of Product Characteristics ( Memento from May 19, 2012 in the Internet Archive ) (technical information, English), as of June 2010.
- ↑ Sativex spray for use in the oral cavity: Specialist information, Almirall Hermal GmbH, as of May 2011.
- ↑ ( Page no longer available , search in web archives: GW Files Sativex Regulatory Submission ), press release May 20, 2009 (English).
