US FDA grants Sativex fast track status for cancer pain

UK-based GW Pharmaceuticals (AIM: GWP), which focuses on its proprietary cannabinoid product platform, today announced that the US Food and Drug Administration has granted Fast Track designation to Sativex, composed primarily of two cannabinoids, for the treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.

Justin Gover, GW’s chief executive, said: “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. 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 FDA's Fast Track program recognizes drugs intended to treat serious or life‑threatening conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA with the aim to speed up the drug’s development, review and potential approval.