Sativex

Sativex is the brand name for nabiximols, a standardized cannabis-derived oromucosal spray delivering an approximately 1:1 ratio of Δ9-THC (2.7 mg) and cannabidiol (2.5 mg) per actuation, plus minor phytocannabinoids and terpenoids. Developed by GW Pharmaceuticals (now Jazz Pharmaceuticals), Sativex was first authorized by Health Canada under a Notice of Compliance with conditions in April 2005 for neuropathic pain in multiple sclerosis (MS), and received full marketing authorization in the United Kingdom from the MHRA in June 2010 for MS-related spasticity inadequately controlled by other antispastic medication. As of early 2022 it was approved in roughly 29 countries, chiefly for adjunctive treatment of MS spasticity, and in Canada also for MS-related neuropathic pain and advanced cancer pain. Sativex is not FDA-approved; the Phase 3 RELEASE MSS1 trial in MS spasticity failed to meet its primary endpoint in 2022, and earlier Phase 3 cancer-pain trials were also negative. → See also: Nabiximols, Multiple sclerosis spasticity.