PMID- 34092180
OWN - NLM
STAT- MEDLINE
DCOM- 20220128
LR  - 20220128
IS  - 1744-8360 (Electronic)
IS  - 1473-7175 (Linking)
VI  - 21
IP  - 7
DP  - 2021 Jul
TI  - Safety and tolerability of nabiximols oromucosal spray: a review of more than 15 
      years" accumulated evidence from clinical trials.
PG  - 755-778
LID - 10.1080/14737175.2021.1935879 [doi]
AB  - Introduction: Nabiximols, a cannabinoid-based oromucosal spray, is indicated as 
      add-on therapy for symptomatic relief of spasticity in persons with multiple 
      sclerosis (MS). This review compiles tolerability and safety data from clinical 
      trials that investigated nabiximols for spasticity and/or chronic pain.Areas 
      covered: Systematic searches identified 38 placebo-controlled randomized 
      controlled trials (RCTs) or post-RCT open-label studies reporting safety data: 15 
      in spasticity; 16 in neuropathic pain; six in chronic cancer pain; and one in 
      rheumatoid arthritis pain. In RCTs, discontinuation rates due to adverse events 
      (AEs) for nabiximols and placebo were lower in spasticity studies (5.4% and 2.8%) 
      than in neuropathic pain (12.9% and 5.3%) or cancer pain (19.5% and 16.6%) 
      studies. The most consistently identified AEs were dizziness, nausea and fatigue 
      in spasticity or neuropathic pain studies; and dizziness, nausea, vomiting and 
      somnolence in cancer pain studies. Serious AE (SAE) rates for nabiximols and 
      placebo were higher in cancer pain (21.8% and 16.9%) than in MS spasticity (4.7% 
      vs. 0.8%) and neuropathic pain (4.1% vs. 3.1%) studies despite similar dose 
      ranges. Treatment-related SAEs showed no particular pattern.Expert opinion: More 
      than 15 years of investigation of nabiximols oromucosal spray in spasticity and 
      chronic pain conditions indicates an acceptable overall safety profile.
FAU - Prieto Gonzalez, Jose Maria
AU  - Prieto Gonzalez JM
AD  - Jefe del Servicio de Neurologia/Neurology Service Head, Hospital Clinico 
      Universitario, Santiago de Compostela, Spain.
FAU - Vila Silvan, Carlos
AU  - Vila Silvan C
AD  - Global Medical Affairs, Almirall S.A., Barcelona, Spain.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20210721
PL  - England
TA  - Expert Rev Neurother
JT  - Expert review of neurotherapeutics
JID - 101129944
RN  - 0 (Drug Combinations)
RN  - 19GBJ60SN5 (Cannabidiol)
RN  - 7J8897W37S (Dronabinol)
RN  - K4H93P747O (nabiximols)
SB  - IM
MH  - *Cannabidiol/adverse effects
MH  - Dronabinol/adverse effects
MH  - Drug Combinations
MH  - Humans
MH  - *Multiple Sclerosis/drug therapy
MH  - Muscle Spasticity/drug therapy
MH  - *Neuralgia/drug therapy
OTO - NOTNLM
OT  - Nabiximols
OT  - Sativex
OT  - chronic cancer pain
OT  - multiple sclerosis
OT  - neuropathic pain
OT  - safety
OT  - spasticity
OT  - tolerability
EDAT- 2021/06/08 06:00
MHDA- 2022/01/29 06:00
CRDT- 2021/06/07 05:23
PHST- 2021/06/08 06:00 [pubmed]
PHST- 2022/01/29 06:00 [medline]
PHST- 2021/06/07 05:23 [entrez]
AID - 10.1080/14737175.2021.1935879 [doi]
PST - ppublish
SO  - Expert Rev Neurother. 2021 Jul;21(7):755-778. doi: 10.1080/14737175.2021.1935879. 
      Epub 2021 Jul 21.