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.

The influence of THC:CBD oromucosal spray on driving ability in patients with multiple sclerosis‐related spasticity

“…The results from the studies and registries reviewed herein did not find any evidence of an increase in motor vehicle accidents associated with THC:CBD oromucosal spray in patients with MS. Furthermore, a majority of patients reported an improvement in driving ability after starting treatment with THC:CBD oromucosal spray, and the authors speculated that this may be related to less spasticity and/or better cognitive function (Etges et al., ).…”

“…A postmarketing risk management registry opened in the UK in 2010, followed by Germany in 2012, and was extended to include Switzerland in 2015 (Etges et al., ). The registry is a noninterventional safety study for patients prescribed THC:CBD oromucosal spray, with the objective of monitoring the emergence of new safety signals that may not be apparent in shorter RCTs, where patients have had to meet stringent eligibility criteria.…”

“…Of the remaining 84 patients, the majority ( n = 63) reported an improvement in driving ability and only 19 patients noted that their ability to drive had deteriorated. The authors speculated that the improvement in driving ability may be related to less spasticity and/or better cognitive function (Etges et al., ).…”

“…Change in driving ability in patients with MS spasticity treated with THC : CBD and who were able to drive when included onto an observational product registry in Germany, Switzerland, and the UK (a) (Etges et al., ), or an observational study in Spain (b) (Oreja‐Guevara, ). (a) Product registry (Germany, Switzerland, and the UK ; n = 387).…”

Posmodernidad, sociedades adictivas, cannabis y comportamiento suicida: ¿Hacia un mundo feliz?

“…Por otra parte, dado que el sistema EC parece tener un cierto papel regulador sobre el sistema opioide (Hurd, 2017), el papel del sistema EC y el uso potencial del Sativex ® podría ser particularmente interesante en el contexto de la teoría de la adicción a los comportamientos suicidas (Blasco-Fontecilla, 2012, Blasco-Fontecilla et al, 2016. De cualquiera de las maneras, cualquier abordaje en este sentido tiene que ser cauteloso porque el también Sativex ® podría aumentar el riesgo de comportamiento suicida en algunos pacientes (Etges et al, 2016).…”