In a time when natural marijuana is considered by the American government to be a gateway to the downtrodden of civil society, it seems odd, but not surprising, that the United States would be champing at the bit to approve cannabis-based medicine.
However, that is exactly what is happening. Despite the fact that the federal government continues to sandbag efforts to remove marijuana from its Schedule I classification, which would ultimately allow patients across the nation to reap the benefits of medical marijuana, the Food and Drug Administration has decided, instead, to speed up the approval process for a pharmaceutical cannabis spay called Sativex.
GW Pharmaceuticals, which has become the Big Pharma of marijuana medicine, announced earlier this week that the FDA has granted the drug “Fast Track designation,” which they hope will allow cannabis-based medicine to be made available to American cancer patients in the near future.
“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, CEO of the United Kingdom’s GW Pharmaceuticals, which is currently in the final stages of clinical trials for the drug.
“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,” he added.
So, how does a cannabis-based drug, which contains a 1:1 ratio of THC and CBD, receive approval for clinical studies in the United States, a country where marijuana is still considered to have “no accepted medical use”? All they had to do was grease the wheels of those responsible for enforcing American drug laws -- a special license from the DEA, which allows the company to import and distribute the drug.
Incidentally, the approval of this marijuana mist will not have any bearing on the current “dangerous substance” classification imposed by the federal government. Instead, the Drug Enforcement Administration has found a way around legal debacle of bringing the pharmaceutical equivalent of marijuana to the marketplace… by planning to list it as a Schedule II or III substance once the drug receives final approval from the FDA.
Results from the Sativex clinical trials are expected to be complete before the end of 2014, with the FDA’s stamp of approval expected to follow soon after. And yes, cancer patients can expect this medication to be expensive. Earlier this year, HIGH TIMES reported that Sativex was costing patients in New Zealand nearly $20,200 per year.
Mike Adams writes for stoners and smut enthusiasts in HIGH TIMES, Playboy’s The Smoking Jacket and Hustler Magazine. You can follow him on Twitter @adamssoup and on Facebook/mikeadams73.