Drug-resistant MS spasticity treatment with Sativex<sup>®</sup>add-on and driving ability

Freidel, M; Tiel-Wilck, Klaus; Schreiber, Herbert; Prechtl, Andreas; Essner, Ute; Lang, Michael

doi:10.1111/ane.12287

Cited by 31 publications

(23 citation statements)

References 26 publications

(42 reference statements)

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“…In the minority of patients who reported a change in driving ability, most saw improvement, thereby supporting previous findings that THC:CBD does not reduce driving ability 20. The reason for this apparent improvement in driving ability is unknown, but may be due to improved spasticity, or cognitive function.…”

Section: Discussionsupporting

confidence: 79%

An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland, who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray

Etges¹,

Karolia²,

Grint³

et al. 2016

TCRM

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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.

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Section: Discussionsupporting

confidence: 79%

An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland, who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray

Etges¹,

Karolia²,

Grint³

et al. 2016

TCRM

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show abstract

“…The specific impact of THC:CBD oromucosal spray treatment on driving ability was investigated in a formal ad hoc observational study in patients with moderate‐to‐severe resistant MS spasticity in Germany (Freidel et al., ). Thirty‐three patients with MS spasticity about to start treatment with add‐on THC:CBD oromucosal spray performed a set of five driving set procedures from a validated computerized test battery at baseline, and the tests were repeated after 4–6 weeks' treatment.…”

Section: Thc:cbdmentioning

confidence: 99%

“…The specific impact of THC:CBD oromucosal spray treatment on driving ability was investigated in a formal ad hoc observational study in patients with moderate-to-severe resistant MS spasticity in Germany (Freidel et al, 2015). No data AUC 0-t , area under the plasma concentration versus time curve (0-designated time); C max , maximum plasma concentration; T max , time to C max .…”

Section: Thc:cbd Oromucosal Spray and Driving: Realworld Data/pharmmentioning

confidence: 99%

“…The chronic, progressive course of MS is associated with physical (muscle paresis and spasticity), sensory (visual and auditory) symptoms, cognitive decline, and psychological impairments that may adversely affect functional independence in terms of activities associated with daily living, including interaction with family and friends, social activities, and ability to work (Freidel et al., ; Ryan et al., ). Mobility is an important component of functional independence, and the ability to drive a car is often integral to independence, social interactions, and activities of daily living such as access to work, family, shopping, and health care (Rapport, Hanks, & Bryer, ).…”

Section: Introductionmentioning

confidence: 99%

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

Celius

Vila

2018

Brain and Behavior

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BackgroundDriving ability is a key function for the majority of patients with multiple sclerosis (MS) to help maintain daily interactions. Both physical and cognitive disability, as well as treatments, may affect the ability to drive. Spasticity is a common symptom associated with MS, and it may affect driving performance either directly or via the medications used to treat it. In this article, we review the evidence relating the antispasticity medicine, Δ9‐tetrahydrocannabinol:cannabidiol (THC:CBD) oromucosal spray (Sativex®), and its potential impact on driving performance.MethodsArticles were identified by searching PubMed from 1/1/2000 to 30/6/2017 using a specified list of search terms. The articles identified using these search terms were augmented with relevant references from these papers and other articles known to the authors.ResultsThe results from THC:CBD oromucosal spray driving studies and real‐world registries did not show any evidence of an increase in motor vehicle accidents associated with THC:CBD oromucosal spray. The majority of patients reported an improvement in driving ability after starting THC:CBD oromucosal spray, and it was speculated that this may be related to reduced spasticity and/or better cognitive function. It should be noted that THC blood levels are significantly lower than the levels associated with recreational use of herbal cannabis.Conclusions THC:CBD oromucosal spray was shown not to impair driving performance. However, periodic assessment of patients with MS driving ability is recommended, especially after relapses and changes in treatment. Blood THC measurements might be above authorized thresholds for some countries following administration of THC:CBD oromucosal spray, thus specific knowledge of each country's driving regulations and a medical certificate are recommended.

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“…Hier finden sich Parallelen zur missbräuchlichen Einnahme ärztlich-verschriebener opioid-haltiger Schmerzmittel. Die indikationsunabhängige Prävalenz wird hier mit 2,1 % für retardierte Präparate und 11,3 % für nicht-retardierte Präparate angegeben [38] [40].…”

Section: Levodopa-induzierte Dyskinesienunclassified

Cannabis bei Parkinson – Hype oder Heilmittel?

Mainka

Stork

Hidding

et al. 2018

Fortschr Neurol Psychiatr

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Cannabis buds and extracts as well as synthetic cannabinoids have been available on prescription to patients with severe diseases since March 2017, with the costs covered by health insurance companies.The prescription of medical marihuana is not restricted to specific symptoms and is therefore also valid for patients with Parkinson's disease. From a legal perspective, patients who are seriously ill even have the right to be treated with cannabis if standard treatment methods are unsuccessful or result in unbearable side effects. This also applies even if only a slight chance of noticeable improvement is predicted as a result of the cannabis treatment.Bearing this in mind and due to an intense media coverage of this topic, more and more patients with Parkinson's disease are requesting cannabis prescription, which is a challenging situation to their neurologists.This article provides an overview of the various cannabis products that can be prescribed, the different modes of administration and the available literature regarding motor- and non-motor symptoms in Parkinson's disease. Furthermore, the authors state their opinion on which indications cannabinoids could be useful in treating patients with Parkinson's disease or in which situation the patient could or even should be prescribed cannabinoids. Additionally, this article presents practical recommendations for the prescription of cannabinoids and patient counseling, e. g., on the effects of medical marijuana on driving capacity.

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Drug-resistant MS spasticity treatment with Sativex^®add-on and driving ability

Abstract: Treatment of MS patients with Sativex(®) does not negatively impact on driving ability and may improve moderate to severe treatment-resistant MS spasticity.

Cited by 31 publications

References 26 publications

An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland, who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray

An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland, who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray

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

Cannabis bei Parkinson – Hype oder Heilmittel?

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Drug-resistant MS spasticity treatment with Sativex®add-on and driving ability

Abstract: Treatment of MS patients with Sativex(®) does not negatively impact on driving ability and may improve moderate to severe treatment-resistant MS spasticity.

Cited by 31 publications

References 26 publications

An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland, who have been prescribed Sativex&reg; (THC:CBD, nabiximols) oromucosal spray

An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland, who have been prescribed Sativex&reg; (THC:CBD, nabiximols) oromucosal spray

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

Cannabis bei Parkinson – Hype oder Heilmittel?

Contact Info

Product

Resources

About

Drug-resistant MS spasticity treatment with Sativex^®add-on and driving ability

An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland, who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray

An observational postmarketing safety registry of patients in the UK, Germany, and Switzerland, who have been prescribed Sativex® (THC:CBD, nabiximols) oromucosal spray