Third Phase 3 Trial of Sativex, Cannabis Extract for MS Spasticity, Planned

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by Patricia Inacio, PhD |

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Jazz Pharmaceuticals is planning to open a third Phase 3 clinical trial of Sativex (nabiximols), an oral spray that contains cannabis extracts, as an add-on treatment for people with multiple sclerosis (MS) and spasticity, the company announced.

Set to start this year, the RELEASE MSS5 trial (NCT04984278) is expected to enroll about 190 adults with any type of MS and spasticity (muscle stiffness and spasms). While study sites are yet to be announced, contact information is available here.

Enrolled patients will first enter a seven-day “baseline” period, during which they maintain their routine anti-spasticity medications, and record their spasticity score and number of daily muscle spasms using an electronic diary.

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After this period, they will be randomly assigned to either Sativex treatment or a placebo, both self-administered as on oral spray in the morning and evening for three weeks. Over the first two weeks, patients can optimize the number of daily sprays (up to a maximum of 12 a day), then maintain that dose for the final week. People who complete this part will then switch their assigned group — those on placebo move to Sativex, and vice versa — for another three weeks.

The trial’s main goal is to assess the effects of treatment on lower limb muscle tone. Secondary objectives include health-related quality of life, and treatment safety and tolerability.

People using an approved disease-modifying MS therapy can continue on that treatment, providing they are on a stable dose for at least three months prior to trial screening and remain on that dose.

Two ongoing Phase 3 trials — RELEASE MSS1 (NCT04657666) and RELEASE MSS3 (NCT04203498) — are also investigating Sativex as a treatment for MS-related spasticity, and continue to enroll eligible patients at sites in Czechia and Poland.

The first has a similar design to RELEASE MSS5, assessing Sativex’s benefits on lower limb muscle tone in 52 adults, while the second aims to include 446 adults to determine the therapy’s effects on the frequency of muscle spasms.

Sativex is an oral spray that contains cannabidiol (CBD) and tetrahydrocannabinol (THC), two of the most abundant cannabinoids found in the cannabis plant.

Originally developed by GW Pharmaceuticals, now part of Jazz, the medication is available in 25 countries — including most of Europe and Canada, but not the U.S. — as an add-on therapy for adults with moderate-to-severe MS spasticity who have failed to respond to other anti-spastic treatments.

“The addition of the GW cannabinoid platform and related pipeline complement and enhance our own growing R&D capabilities, accelerating our ability to improve the lives of patients,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals.

“The shared values and patient-centricity among the Jazz and GW teams … will further enhance our ability to innovate and execute, including the planned [initiation of] the third Phase 3 nabiximols clinical trial in multiple sclerosis-related spasticity,” said Robert Iannone, MD, executive vice president, research and development and chief medical officer of Jazz Pharmaceuticals.

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