title: An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland who have been prescribed Sativex®(THC:CBD, nabiximols) oromucosal spray.
abstract: The global exposure of Sativex®(Δ9-tetrahydrocannabinol [THC]:cannabidiol [CBD], nabiximols) is estimated to be above 45,000 patient-years since it was given marketing approval for treating treatment-resistant spasticity in multiple sclerosis (MS). An observational registry to collect safety data from patients receiving THC:CBD was set up following its approval in the UK, Germany, and Switzerland, with the aim of determining its long-term safety in clinical practice. Twice a year, the Registry was opened to prescribing physicians to voluntarily report data on patients' use of THC:CBD, clinically significant adverse events (AEs), and special interest events. The Registry contains data from 941 patients with 2,213.98 patient-years of exposure. Within this cohort, 60% were reported as continuing treatment, while 83% were reported as benefiting from the treatment. Thirty-two percent of patients stopped treatment, with approximately one third citing lack of effectiveness and one quarter citing AEs. Psychiatric AEs of clinical significance were reported in 6% of the patients, 6% reported falls requiring medical attention, and suicidality was reported in 2%. Driving ability was reported to have worsened in 2% of patients, but improved in 7%. AEs were more common during the first month of treatment. The most common treatment-related AEs included dizziness (2.3%) and fatigue (1.7%). There were no signals to indicate abuse, diversion, or dependence. The long-term risk profile from the Registry is consistent with the known (labeled) safety profile of THC:CBD, and therefore supports it being a well-tolerated and beneficial medication for the treatment of MS spasticity. No evidence of new long-term safety concerns has emerged.
authors.affiliation: GW Pharmaceuticals, Cambridge, UK.
authors.forename: Tilden
authors.initials: T
authors.lastname: Etges
authors.affiliation: GW Pharmaceuticals, Cambridge, UK.
authors.forename: Kari
authors.initials: K
authors.lastname: Karolia
authors.affiliation: GW Pharmaceuticals, Cambridge, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Grint
authors.affiliation: GW Pharmaceuticals, Cambridge, UK.
authors.forename: Adam
authors.initials: A
authors.lastname: Taylor
authors.affiliation: GW Pharmaceuticals, Cambridge, UK.
authors.forename: Heather
authors.initials: H
authors.lastname: Lauder
authors.affiliation: GW Pharmaceuticals, Cambridge, UK.
authors.forename: Brian
authors.initials: B
authors.lastname: Daka
authors.affiliation: GW Pharmaceuticals, Cambridge, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Wright
keywords: cannabidiol; multiple sclerosis; non-interventional; risk management plan; spasticity; tetrahydrocannabinol