Sativex eases MS spasticity and related symptoms in real-life study

Real-world use of nabiximols, an oral spray cannabinoid treatment, was associated with a self-reported easing of spasticity and related symptoms for people with multiple sclerosis (MS), according to a recent study in Austria.

Most patients (87.5%) said they were at least partly satisfied with the therapy — available as Sativex — after three months of its use, in contrast to about 30% who were satisfied with previous antispasticity treatments.

These findings indicate “nabiximols is an option for patients with MS spasticity who fail first-line oral antispasticity treatment,” the researchers wrote.

The study, “Non-interventional, prospective, observational study on spasticity-associated symptom control with nabiximols as add-on therapy in patients with multiple sclerosis spasticity in Austria,” was published in Brain and Behavior.

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Study patients reporting 7.7 years of spasticity and related symptoms

Spasticity, marked by muscle stiffness and involuntary muscle contractions, is a common MS symptom. About 90% of patients experience it in some form during the disease’s course.

It can also be associated with restricted mobility, fatigue, bladder issues, disturbed sleep, and other symptoms with a “cumulative negative impact on patients’ daily activities and quality of life,” the researchers wrote.

There is “a need to look beyond spasticity itself when assessing clinical benefit in patients with MS,” they added.

Marketed by Jazz Pharmaceuticals, Sativex is an oral spray to the mouth containing extracts from the cannabis plant — mainly tetrahydrocannibinol and cannabidiol.

While not approved for use in the U.S., Sativex is available in countries that include Canada and most of Europe.

Its mechanisms aren’t fully understood, but findings indicate that Sativex as an add-on therapy may ease spasticity for some MS patients, in addition to associated symptoms like pain or sleep problems. Still, its potential benefits remain controversial, and it is not found to be effective in all studies.

Scientists in Austria conducted an observational study to evaluate the real-world effects of Sativex on up to 55 patients given the medication at MS centers across that country.

Most of these patients were women (60%), and all had a median age of 52.5. About half had secondary progressive MS (50.9%), and the others had either a primary progressive (32.7%) or a relapsing-remitting (16.4%) disease course.

They had been experiencing spasticity-related symptoms for a mean of 7.7 years, most commonly restricted mobility and greater muscle tone/stiffness. These symptoms were largely of moderate or severe intensity.

A majority had tried other spasticity medications and/or non-pharmaceutical interventions like physical therapy. At the time of starting with Sativex, 61.8% still were using non-pharmaceutical approaches, mainly physiotherapy, and 63.6% were using antispasticity medications, mainly baclofen or tizanidine (brand name, Zanaflex; generics available).

Patients’ main reasons for adding Sativex to an ongoing regimen were insufficient effectiveness or poor tolerance to previous therapies.

Easing in spasm frequency, severity with Sativex as an add-on treatment

Sativex dosing is typically increased slowly based on tolerability and clinical response. After a mean follow-up of 89 days (nearly three months), the mean dose was 7.2 oral sprays per day.

Three months of its add-on use did not reduce the proportion of patients experiencing muscle spasms, but it lowered spasm frequency by 68.2% — from a mean of 10.7 spasms a day to 3.4 spams a day, results showed. Spasticity severity also was reported to ease by 39% at three months.

Notably, Sativex’s use eased several other spasticity-associated symptoms after one month of treatment, and these benefits were either stable or greater after three months.

Specifically, the medication resulted in a 47.2% reduction in overall sleep impairment scores after three months, and fatigue and pain due to spasticity declined by 26.4% and 40.4%, respectively.

All of these improvements neared or surpassed the 30% threshold that generally marks a clinically relevant improvement, the researchers wrote.

While the proportion of patients with urinary incontinence, or leaky bladder, did not notably change after three months of treatment, the frequency of such episodes decreased from 16.6 per week to 5.1 per week at three months — a significant, 69.3% reduction.

No changes were noted in patients’ ability to perform daily activities, with about three-quarters of participants consistently reporting that spasticity restricted such activities often or every day. This could be due in part to patients’ relatively advanced stage of MS, the researchers noted. Their mean time since diagnosis was 15.1 years.

Most patients (87.5%) reported being at least partly satisfied with Sativex after three months, while 30.2% said they were satisfied with their previous spasticity treatments.

No “obvious differences” in patient response to the treatment was seen in analyses based on MS type or patient’s sex, the study noted.

Most reported side effects were consistent with Sativex’s known safety profile and included fatigue, vertigo, lack of energy, and sleepiness. Fifteen of 19 patients reporting side effects stopped the treatment early.

According to the scientists, these findings suggest that “patients with MS spasticity who respond to nabiximols [Sativex] may perceive amelioration of associated symptoms,” which may occur independently of beneficial changes with spasticity itself.