In a surprise move, the USA Food & Drug Administration (FDA) has given Fast Track designation to Sativex® for the treatment of pain in patients with advanced cancer. The move is designed to help the cancer sufferers who find that opioid medicines are simply ineffective. Sativex is currently in Phase 3 clinical trials for this, and the fast-track status will mean that sativex can avoid some of the lengthy bureaucracy which would delay the trial. Sativex is a whole-plant cannabis extract which has a 1:1 ratio of THC:CBD in the form of an oral spray. It is licensed for use in numerous countries as a treatment for MS muscle stiffness, but many people expect it will eventually be licensed for many more medical applications in the future.
In reality this will most likely mean that the review and approval process can be processed quicker than usual. No doubt this is regarded as a ‘low risk’ fast-track since there is absolutely no scientific evidence that cannabis presents any unknown side effects. The opposite is true, cannabis has been widely used for decades by millions of people as an organic and natural alternative to prescription medicines for pain relief across a whole range of conditions.
"The award of Fast Track designation for Sativex represents important recognition by the FDA of the potential of this medicine to address significant unmet needs in the treatment of cancer pain," said Justin Gover who is GW's Chief Executive Officer. "Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications. We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn.”
This is great news for medical marijuana, not only does it infer that the official medical establishment is starting to understand the role of cannabis for cancer treatment. But it also indicates that Governments are starting to accept that cannabis really does have other important medical uses without the nasty side effects of other prescription treatments.
More information is here https://www.marketwatch.com/story/gw-pharmaceuticals-announces-that-sativex-receives-fast-track-designation-from-fda-in-cancer-pain-2014-04-28
May 2nd 2014
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