Salisbury, United Kingdom: Health Canada granted regulatory approval this week to Sativex, an oral spray consisting of natural cannabis extracts, 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.
Produced by the British biotechnology firm GW Pharmaceuticals, 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.
“This event marks the world’s first approval of a [natural] cannabis-derived medicine,” said GW Pharmaceuticals Executive Chairman Geoffrey Guy. The company, along with its partner Bayer AG, is expected to begin negotiations with the Food and Drug Administration later this year regarding opportunities to bring Sativex to the US market.
GW is expected to seek further approval from Health Canada to market Sativex for additional therapeutic indications. Recent clinical trials on Sativex found that it significantly reduced pain in cancer patients compared to placebo, and relieved urinary dysfunction in patients suffering from advanced Multiple Sclerosis.
Although regulatory approval for Sativex in the United Kingdom remains pending, an advisory body of the British Medicines and Health products Regulatory Agency (MHRA) announced in December that it required further clinical evidence of Sativex’s ability to alleviate MS-associated spasticity in a “clinically relevant” manner before the agency would consider approving the drug for licensing in the UK.
GW Pharmaceuticals also announced this week that it had hired former White House Drug Czar Deputy Director Andrea Barthwell in an advisory capacity. As Deputy Director, Barthwell lobbied against legislative efforts to legalize the medical use of whole smoked cannabis by qualified patients. “Having this product (Sativex) available will certainly slow down the dash to make the crude plant material available to patients across the country,” Barthwell told the Los Angeles Times Wednesday.
Responding to Barthwell’s statement, NORML Executive Director Allen St. Pierre, said, “We are pleased that Sativex may one day offer a legal option for US patients and physicians. However, patients who choose to use whole smoked cannabis therapeutically under their doctor’s supervision should not have to live in fear of arrest or incarceration for using their chosen medication.”
For more information, please contact either Allen St. Pierre or Paul Armentano of NORML at (202) 483-5500.