Advances in the management of MS symptoms: real-life evidence

Neurodegener Dis Manag. 2015;5(6 Suppl):19-21. doi: 10.2217/nmt.15.66.

Abstract

Once the efficacy and tolerability of a new intervention have been demonstrated in clinical trials under ideal experimental conditions, observational studies within approved label conditions are performed to determine its effectiveness in real-world use and expand the safety/tolerability data. Several large observational studies have been conducted of Sativex(®) (THC:CBD) oromucosal spray as add-on therapy for moderate-to-severe treatment-resistant multiple sclerosis (MS) spasticity. Studies performed to date with a focus on tolerability have confirmed the absence of abuse, misuse, addiction and lack of impairment of cognition or driving ability. Open-label studies performed to date with a focus on effectiveness have indicated that about one-half to two-thirds of patients initiated on THC:CBD oromucosal spray continue to derive benefit after 3 months' treatment at a mean dosage of 5-7 sprays/day.

Keywords: Sativex; THC:CBD oromucosal spray; effectiveness; multiple sclerosis; observational studies; review; safety; spasticity.

Publication types

  • Review

MeSH terms

  • Activities of Daily Living
  • Cannabidiol
  • Disease Management*
  • Dronabinol
  • Drug Combinations
  • Humans
  • Multiple Sclerosis / complications
  • Multiple Sclerosis / therapy*
  • Muscle Spasticity / drug therapy
  • Muscle Spasticity / etiology
  • Plant Extracts / adverse effects
  • Plant Extracts / therapeutic use
  • Product Surveillance, Postmarketing

Substances

  • Drug Combinations
  • Plant Extracts
  • Cannabidiol
  • Dronabinol
  • nabiximols