Sativex Spray Approved for MS Neuropathic Pain, With Trials Showing Benefit for Spasticity and Sleep | Research

The takeaway

Five randomized controlled trials of Sativex (THC:CBD oromucosal spray) involving 368 neurological patients showed significant reductions in neuropathic pain, spasticity, muscle spasms, and sleep disturbance, leading to approval in Canada for MS neuropathic pain.

Read this if you want to understand the clinical trial evidence behind the first approved cannabis-based pharmaceutical.

368 patients across 5 RCTs showed significant improvements in pain, spasticity, and sleep

What the researchers found

Sativex, containing THC and CBD in a 1:1 ratio delivered as an oromucosal spray, was one of the first cannabis-based medicines to undergo conventional clinical development and receive prescription approval. Five randomized controlled trials compared Sativex with placebo in a total of 368 patients with various neurological conditions including MS.

In some trials, Sativex significantly reduced neuropathic pain, spasticity, muscle spasms, and sleep disturbances. The most common adverse events were dizziness, sleepiness, fatigue, feeling of intoxication, and bad taste.

Sativex was approved in Canada as adjunctive treatment for neuropathic pain in MS patients. It is regulated as a narcotic. Long-term safety and the potential for dependence, abuse, misuse, and diversion remained unknown at the time of this review.

Why it matters

Sativex represented a milestone in cannabis medicine: the first cannabis-derived pharmaceutical to achieve regulatory approval through standard clinical trial processes. Its approval validated the concept that cannabis-based medicines could meet the same standards as conventional pharmaceuticals.

The numbers in context

5 RCTs reviewed. 368 patients total. THC:CBD ratio: 1:1. Each spray delivers 2.7 mg THC + 2.5 mg CBD. Approved indication: neuropathic pain in MS. Significant improvements in: neuropathic pain, spasticity, muscle spasms, sleep disturbance.

How the study worked

Health technology assessment reviewing five randomized controlled trials comparing THC:CBD oromucosal spray with placebo. Total of 368 patients with various neurological conditions including MS. Assessed benefits and harms across trials.

What this study cannot tell us

Only 368 patients across all five trials, limiting the power to detect rare adverse events. Long-term safety data was not available. The review noted that potential for dependence, abuse, and diversion was unknown. Only neurological conditions were studied.

How to read the evidence

Health technology assessment based on five randomized controlled trials. Moderate overall evidence with consistent findings across trials but relatively small total sample size.

When this study was published

Published in 2005. Sativex has since been approved in over 25 countries and extensive post-marketing safety data is now available.

The bigger picture

Sativex's approval pathway became a model for cannabis-based medicine development. Since this review, Sativex has been approved in over 25 countries for MS spasticity, establishing that cannabis-derived medicines can navigate the pharmaceutical regulatory process.

Questions still open

Will long-term use reveal additional safety concerns not seen in short-term trials? Can Sativex be effective for pain conditions beyond MS?

Common questions

What is Sativex?

Sativex is a mouth spray containing THC and CBD in a 1:1 ratio, derived from the cannabis plant. Each spray delivers 2.7 mg THC and 2.5 mg CBD. It was one of the first cannabis-based medicines approved through conventional pharmaceutical regulatory processes.

What side effects does Sativex have?

The most common side effects in clinical trials were dizziness, sleepiness, fatigue, feeling of intoxication, and bad taste. No serious toxicity was reported in the trials, though long-term safety data was not available at the time of this review.

Read the original research

Sativex for the management of multiple sclerosis symptoms.

Issues in emerging health technologies, 1-4

View on PubMed ↗

Citation

Perras C. (2005). Sativex for the management of multiple sclerosis symptoms.. Issues in emerging health technologies, 1-4.