Cannabis-Based Treatment Effective in Neuropathic Pain and
Spasticity: Presented at EFNS
GLASGOW, UK
The investigative agent Satirex®, which contains a standardised formulation of delta-9-
tetrahydrocannabinol (THC) and cannabidiol (CBD), is efficacious and
well tolerated during long-term use in patients with neuropathic pain
(NP) of various aetiologies or with spasticity due to multiple
sclerosis (MS), according to a placebo-controlled, clinical study.
Mick Serpell, MBCHB, Co-Investigator and Senior Lecturer, Department
of Anaesthesia and Pain Medicine, Western Infirmary, Glasgow
University, Glasgow, United Kingdom, presented the findings here on
September 4[th at the 10th Congress of the European Federation of
Neurological Societies (EFNS).
Satirex contains standardised levels of THC and CBD that are produced
from selected strains of Cannabis sativa. The agent is formulated
into a spray that is designed to deliver 2.7 mg of THC and 2.5 mg of
CBD per 100 mcL when used for oromucosal administration.
The researchers evaluated the effects Satirex in an open-label
extension of 4 clinical, double-blind, randomised, controlled trials,
at the end of which patients were offered to go into the open-label
extension, as a 1-year follow-up, to evaluated long-term patient
tolerance and side effects, the study's primary objective.
The secondary objectives related to possible tolerance to Satirex, as
assessed by its efficacy towards NP of various aetiologies and
spasticity due to MS.
The cohort consisted of 507 patients with a mean age of 50 years
(male, 43%), who represented 74% of those who had participated in the
parent eligibility trials. These were primarily of Caucasian ethnic
origins (96%), and 47% had had previous cannabis use. Of these, 262
(52%) withdrew from the study for a range of reasons, where 85 (17%)
were due to all causality adverse events from the study medication.
Satirex was applied as a sublingual spray, with subject self-
titration of the dose within the maximum permissible use of 8
actuations in a 3-hour period, and 48 in 24 hours. This led to
Satirex use of from 5 to 9 actuations per day, where the mean dose
remained relatively stable to 52 weeks, which indicated the absence
of development of tolerance.
For the 2 study groupings of pain (centre NP; pain in MS), symptom
severity numeric rating scale (NRS) scores showed an initial
improvement in the pain over that seen in the parent trial, and this
was maintained up to 100 weeks. Similarly, bladder dysfunction
severity NRS score and spasticity severity NRS score both showed
initial and maintained benefits of Satirex up to 44 and 92 weeks.
Sleep quality was also rated across these patients with NP and MS,
with the majority also experiencing initial (to week 4) improvements
in sleep quality that were maintained and further improved to 52 weeks.
Over this long-term use of Satirex, 94% of subjects experienced at
least 1 adverse event, with the majority of adverse events being mild
or moderate in severity, the researchers said.
Treatment-related adverse events were seen in 85% of subjects, with
the most prevalent being dizziness (26.8%), nausea (12.6%), fatigue
(9.1%), diarrhoea (8.1%), somnolence (7.9%), dry mouth (7.7%),
dysgensia (7.5%) and headache (6.5%). The greatest proportion of
these adverse events was seen in subjects with nervous system
disorders (49.5%), gastrointestinal disorders (44.6%) and general
disorders, and administration site conditions (35.7%).
While 14.6% of subjects experienced serious adverse events, 3.2% were
considered to be treatment related, the most common of which were
gastrointestinal disorders. Of the 4 deaths that occurred during the
study, 2 were not medication related, 1 was from lung cancer after
Satirex discontinuation, and 1 patient was aspiration pneumonia,
which was considered to be Satirex related.
There were no significant changes from baseline in laboratory
parameters (biochemistry, haematology, urine analysis), and there
were no long-term effects on vital signs and electrocardiograms.
Dr. Seppell stressed that the benefits seen with Satirex in these
patients groups were maintained for up to 1 year without development
of tolerance, and with acceptable safety and tolerability.
This study was sponsored by GW Pharma Ltd.