GW Pharmaceuticals, a biopharmaceutical company with a proprietary cannabinoid product platform, says that the US FDA has granted Fast Track designation to Sativex for the treatment of pain in patients with advanced cancer, who experience inadequate pain relief during opioid therapy.
Sativex is in Phase III clinical trials for this indication. What this status does is it grants the drug program better access to the regulatory agency during drug development, review, and approval.
"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, GW Pharma CEO. "Sativex is the only non-opioid treatment currently in Phase III 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 company refers to Sativex as an "investigational product" but that only applies in the US, as the drug is approved in 25 other countries for spasticity due to Multiple Sclerosis.
Sativex is composed of two cannabinoids: CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol). The drug is administered as a metered dose oromucosal spray.
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