A pioneering cannabis-based medicine for multiple sclerosis from GW Pharmaceuticals has been filed for approval in Europe, paving the way for its potential approval at the end of 2009 or early in 2010.
Following numerous delays, the submission to regulators in Britain and Spain is a landmark for the British drugmaker, which also announced it had made a maiden net profit of 4.0 million pounds ($NZ10.50 million) in the six months to March 31 from a 4.2 million loss a year ago.
Clinical trials have shown GW’s drug Sativex, which is sprayed under the tongue, reduces spasticity in multiple sclerosis patients who do not respond adequately to existing therapies.
Sativex became the world’s first cannabis medicine to win regulatory approval when it was approved in Canada in 2005.
The drug — extracted from marijuana plants grown at secret locations in the English countryside — has been hit by a string of delays in Europe, where GW originally hoped to win approval in 2003.
The spray contains two active cannabinoids, CBD and THC. The latter substance is responsible for the euphoria associated with smoking cannabis.
GW also said it was planning a mid-stage Phase II clinical trial with a new cannabinoid medicine for the treatment of dyslipidaemia, or raised levels of fat in the blood, in type II diabetes patients.
Other potential use for cannabinoid medicines could include treatments for cancer and schizophrenia.
“We’re looking at developing other products from the plant which are not psychoactive … The plant has 60 or 70 of them, many of which have a very interesting pharmacology,” R&D Director Stephen Wright told Reuters.
via Cannabis drug for MS – wellbeing – life-style | Stuff.co.nz.
The drug is awaiting approval in the US, where it cannot be approved. I don’t mean literally – sure they could approve it. But then what will they say to thirteen medical marijuana states who complain marijuana is mis-scheduled as having “no recognized medical use” in the United States when its whole plant extract is approved for medical use? How do you ban the plant containing THC and CBD but allow the spray containing the very same thing? The same way they allow Marinol but ban marijuana, I suppose, by saying that Marinol is one cannabinoid of guaranteed purity and dosage. But the more of these cannabinoids the new drugs contain, the closer they are to raw cannabis and the more tenuous that argument becomes.
Then what happens when they start using the spray THC and CBD to treat cancer and schizophrenia, after telling us for years that the inhaled THC and CBD will cause cancer and schizophrenia? And then what happens when they start finding many more medical uses for the other 60-odd cannabinoids? At what point do they realize what we all know – that the whole plant is better than the sum of its parts?


I read that sativex had caused a death in the UK. http://tr.im/nX9w
Any news on this?