London, United Kingdom: The federal regulatory agency that oversees the licensing of prescription medications in the UK has rejected an appeal by biotechnology company GW Pharmaceuticals to market its cannabis extract spray Sativex, according to a Reuters News Wire report. In December, Britain’s Committee on the Safety of Medicines informed the company that Sativex would have to undergo additional clinical trials before it could be licensed in the UK. GW Pharmaceuticals had appealed that decision.
The Reuters story cited an “unidentified government source” affirming that Britain’s Medicines Commission had recently heard GW’s appeal and rejected it. A prepared statement on GW’s website confirms that their appeal was considered by the agency, but states that “GW has yet to be informed of any recommendation made by the Commission.”
Sativex is a whole plant medicinal cannabis extract containing precise doses of the cannabinoids THC and cannabidiol (CBD), as well as naturally existing terpenoids (oils) and flavonoids (antioxidants). In clinical trials, Sativex has been demonstrated to alleviate numerous MS-associated symptoms compared to placebo, including pain, muscle spasms, and bladder incontinence.
In April, Health Canada granted regulatory approval to Sativex for the treatment of neuropathic pain associated with Multiple Sclerosis. The spray is expected to be available to the Canadian public by prescription later this spring.
For more information, please contact either Allen St. Pierre or Paul Armentano of NORML at (202) 483-5500.