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Delta-9-tetrahydrocannabinol/cannabidiol (Sativex®): a review of its use in patients with moderate to severe spasticity due to multiple sclerosis.

Abstract

Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) [Sativex®] is an oromucosal spray formulation that contains principally THC and CBD at an approximately 1:1 fixed ratio, derived from cloned Cannabis sativa L. plants. The main active substance, THC, acts as a partial agonist at human cannabinoid receptors (CB1 and CB2), and thus, may modulate the effects of excitatory (glutamate) and inhibitory (gamma-aminobutyric acid) neurotransmitters. THC/CBD is approved in a number of countries, including Germany and the UK, as an add-on treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. In the largest multinational clinical trial that evaluated the approved THC/CBD regimen in this population, 12 weeks' double-blind treatment with THC/CBD significantly reduced spasticity severity (primary endpoint) compared with placebo in patients who achieved a clinically significant improvement in spasticity after 4 weeks' single-blind THC/CBD treatment, as assessed by a patient-rated numerical rating scale. A significantly greater proportion of THC/CBD than placebo recipients achieved a ≥ 30% reduction (a clinically relevant reduction) in spasticity severity. The efficacy of THC/CBD has been also shown in at least one everyday clinical practice study (MOVE 2). THC/CBD was generally well tolerated in clinical trials. Dizziness and fatigue were reported most frequently during the first 4 weeks of treatment and resolved within a few days even with continued treatment. Thus, add-on THC/CBD is a useful symptomatic treatment option for its approved indication.

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  • Authors+Show Affiliations

    ,

    Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand, demail@springer.com.

    ,

    Source

    Drugs 74:5 2014 Apr pg 563-78

    MeSH

    Adult
    Cannabidiol
    Cannabinoid Receptor Agonists
    Dronabinol
    Drug Combinations
    Humans
    Multiple Sclerosis
    Muscle Spasticity
    Plant Extracts
    Receptor, Cannabinoid, CB1
    Receptor, Cannabinoid, CB2
    Severity of Illness Index

    Pub Type(s)

    Journal Article
    Review

    Language

    eng

    PubMed ID

    24671907

    Citation

    Syed, Yahiya Y., et al. "Delta-9-tetrahydrocannabinol/cannabidiol (Sativex®): a Review of Its Use in Patients With Moderate to Severe Spasticity Due to Multiple Sclerosis." Drugs, vol. 74, no. 5, 2014, pp. 563-78.
    Syed YY, McKeage K, Scott LJ. Delta-9-tetrahydrocannabinol/cannabidiol (Sativex®): a review of its use in patients with moderate to severe spasticity due to multiple sclerosis. Drugs. 2014;74(5):563-78.
    Syed, Y. Y., McKeage, K., & Scott, L. J. (2014). Delta-9-tetrahydrocannabinol/cannabidiol (Sativex®): a review of its use in patients with moderate to severe spasticity due to multiple sclerosis. Drugs, 74(5), pp. 563-78. doi:10.1007/s40265-014-0197-5.
    Syed YY, McKeage K, Scott LJ. Delta-9-tetrahydrocannabinol/cannabidiol (Sativex®): a Review of Its Use in Patients With Moderate to Severe Spasticity Due to Multiple Sclerosis. Drugs. 2014;74(5):563-78. PubMed PMID: 24671907.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Delta-9-tetrahydrocannabinol/cannabidiol (Sativex®): a review of its use in patients with moderate to severe spasticity due to multiple sclerosis. AU - Syed,Yahiya Y, AU - McKeage,Kate, AU - Scott,Lesley J, PY - 2014/3/28/entrez PY - 2014/3/29/pubmed PY - 2015/6/16/medline SP - 563 EP - 78 JF - Drugs JO - Drugs VL - 74 IS - 5 N2 - Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) [Sativex®] is an oromucosal spray formulation that contains principally THC and CBD at an approximately 1:1 fixed ratio, derived from cloned Cannabis sativa L. plants. The main active substance, THC, acts as a partial agonist at human cannabinoid receptors (CB1 and CB2), and thus, may modulate the effects of excitatory (glutamate) and inhibitory (gamma-aminobutyric acid) neurotransmitters. THC/CBD is approved in a number of countries, including Germany and the UK, as an add-on treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. In the largest multinational clinical trial that evaluated the approved THC/CBD regimen in this population, 12 weeks' double-blind treatment with THC/CBD significantly reduced spasticity severity (primary endpoint) compared with placebo in patients who achieved a clinically significant improvement in spasticity after 4 weeks' single-blind THC/CBD treatment, as assessed by a patient-rated numerical rating scale. A significantly greater proportion of THC/CBD than placebo recipients achieved a ≥ 30% reduction (a clinically relevant reduction) in spasticity severity. The efficacy of THC/CBD has been also shown in at least one everyday clinical practice study (MOVE 2). THC/CBD was generally well tolerated in clinical trials. Dizziness and fatigue were reported most frequently during the first 4 weeks of treatment and resolved within a few days even with continued treatment. Thus, add-on THC/CBD is a useful symptomatic treatment option for its approved indication. SN - 1179-1950 UR - https://www.unboundmedicine.com/medline/citation/24671907/Delta_9_tetrahydrocannabinol/cannabidiol__Sativex®_:_a_review_of_its_use_in_patients_with_moderate_to_severe_spasticity_due_to_multiple_sclerosis_ L2 - https://dx.doi.org/10.1007/s40265-014-0197-5 DB - PRIME DP - Unbound Medicine ER -