Trial Results a Setback for US Approval of Nabiximols for MS Spasticity

This news seems disappointing: A Phase 3 clinical trial of nabiximols — which is available under the brand name Sativex in several countries, including Canada and most of Europe — has failed to meet its primary goal of reducing leg spasticity in people with multiple sclerosis (MS).

Nabiximols is an oral spray containing THC and CBD extracted from the cannabis plant. THC is the primary psychoactive component of cannabis, while CBD provides a calming effect. CBD is sometimes used as a seizure medication, and some scientists believe that when combined with THC, it can offset the “high” that THC produces. They’re sort of like yin and yang.

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In the failed study, named RELEASE MSS1, 68 adults with poorly controlled MS spasticity received either nabiximols as an add-on therapy to their regular spasticity medication, or a placebo, for three weeks, according to MS News Today’s Lindsey Shapiro. The goal of a change in the patient’s lower limb muscle tone, as measured by the Modified Ashworth Scale, was not achieved. The results showed that nabiximols failed to reduce leg spasticity in the participants who received it.

Data from RELEASE MSS1 will be presented at an upcoming medical conference, the trial’s sponsor, Jazz Pharmaceuticals, said in a press release.

Earlier studies reported better results

In early 2020, Forest Ray reported in MS News Today on a Sativex study in Germany named SAVANT, which was published in the International Journal of Neuroscience. The study concluded that using Sativex, along with another spasticity medication, relieved both the pain and the severity of MS spasticity in participants.

Additionally, a retrospective study of Sativex in Belgium, published in the journal BMC Neurology in June 2021, reported that more than 60% of participants had a “clinically relevant symptomatic effect” after using Sativex as an add-on therapy for the 12-week study period.

What all of this suggests to me is that perhaps nabiximols isn’t effective as a stand-alone treatment. 

One user’s experience was mixed

A reader of this column who lives in Belgium and has used nabiximols said it helps, somewhat. Daniel Verbeke told me last year that the spasticity in his right leg decreased after using it, and he felt like using his walking stick more often, rather than using his wheelchair or scooter. He said he saw no spectacular improvements, yet it was helping enough for him to continue using the medication.

Jazz studies aimed at US approval will continue

“We look forward to additional data from two other ongoing trials that have the potential to support a U.S. FDA [Food and Drug Administration] New Drug Application submission,” Jazz Pharmaceutical’s head of research and development, Rob Iannone, said. Those studies are RELEASE MSS3, with 446 participants, and RELEASE MSS5, with 190. The studies are expected to conclude next year.

So maybe the news isn’t as disappointing as it could be.

If you’ve had an experience with Sativex (nabiximols), I’d like to hear about it in the comments below. You’re also invited to visit my personal website at www.themswire.com.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.