A cancer analgesic has been awarded fast track status by the US Food and Drug Administration.
The US Food and Drug Administration (FDA) has designated fast track status to a novel non-opioid cancer analgesic in development, GW Pharmaceuticals announced.
Composed mainly of cannabidiol (CBS) and delta 9 tetrahydrocannabinol (THC), Sativex is a pain treatment for patients with advanced cancer who experience inadequate pain reduction during chronic opioid therapy. Currently, the drug is undergoing a phase 3 clinical trial, which will be completed by the end of 2014. It is administered as a metered dose oromucosal spray.
“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,” GW Chief Executive Officer Justin Gover explained in a press release. “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.”
The FDA grants fast track status to developmental drugs intended to treat serious or life-threatening conditions and fulfill currently unmet needs. The program is designed to speed the development, review, and potential approval process of the drug.
Sativex is currently approved in 25 countries, mostly in Europe, for spasticity due to multiple sclerosis (MS).