U.S. health authorities hope to accelerate the approval of Sativex, a cannabis-based spray in final stages of clinical research as a treatment for cancer pain.
GW Pharmaceuticals, the company behind Sativex, announced Monday that the drug has been granted Fast Track designation by the FDA. The status is meant to provide quicker review of treatments that show early promise.
“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 GW Pharmaceuticals.
“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.”
Sativex is a whole cannabis extract that contains an equal 1:1 ratio of the plant’s two main ingredients, THC and CBD. The drug is currently approved in 25 countries – including Canada, the UK and Switzerland – for the treatment of multiple sclerosis related symptoms.“We are fully committed to delivering the first FDA-approved cannabinoid medicine”Although not yet approved in the U.S., GW, in collaboration with Japanese pharmaceutical giant Otsuka, has made progress over the years in proving the drug’s ability to manage pain from cancer.
One roadblock has been the classification of marijuana under federal law, which still considers the plant to have “no accepted medical use.” To import Sativex from its production site in the UK, the company had to obtain a license from the DEA.
The drug must also be kept at a secure distribution facility, from where it is shipped to about 40 hospitals and pain centers across the country that are currently involved with trials.
On the other hand, FDA approval of Sativex won’t likely affect marijuana’s scheduling. According to a spokesperson for the DEA, the agency expects Sativex (or nabiximols) to be listed as a Schedule 2 or 3 controlled substance.
GW anticipates final results from Phase 3 trials to be available by the end of 2014. The company is also conducting trials on cannabis-based drugs for epilepsy, brain cancer, schizophrenia, ulcerative colitis and diabetes.