Cannabis-Derived MS Treatment Disappoints in Phase III Trial

Sativex failed to show improvements. (Courtesy Michael Vi/Shutterstock)

Sativex failed to show improvements. (Courtesy Michael Vi/Shutterstock)

Initial results from Jazz Pharmaceuticals' Phase III study of Sativex (JZP378) for the treatment of multiple sclerosis failed to achieve the primary endpoint of an improvement in muscle tone.

The researchers for the RELEASE MSS1 study had hoped for a significant change in lower limb muscle tone-6 (LLMT-6) by day 21, based on the Modified Ashworth Scale (MAS), but failed. Secondary endpoints were lower limb muscle tone-4 (LLMT-4) changes based on MAS, safety and tolerability. 

Regarding safety, the trial demonstrated consistency with adverse events observed in previous tests. No new safety issues came up.

"We remain committed to the nabiximols program and are actively assessing the RELEASE MSS1 trial results, which will be presented at a future medical meeting. We look forward to additional data from two other ongoing trials that have the potential to support a U.S. Food and Drug Administration submission," Rob Iannone, M.D, M.S.C.E., executive vice president and global head of research and development at Jazz, said in a statement.

Sativex, approved in the United Kingdom in 2010 for the same indication, is a nabiximols oromucosal spray made from cannabis sativa plant extracts. It contains cannabinoids delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), and other related components. Sativex is also approved in 29 countries to treat adults diagnosed with moderate to severe spasticity due to multiple sclerosis who did not respond well to other anti-spasticity drugs.

The RELEASE MSS1 trial, the first and smallest of three clinical studies in Jazz's Sativex evaluation program, is observing 68 participants with MS spasticity. This trial's results and two other ongoing Phase III studies will be used to determine the drug's readiness for approval. The other two trials, RELEASE MSS3 and RELEASE MSS5, involve 446 and 190 participants, respectively, evaluating Sativex over 12-week and three-week periods.

As of this writing, no U.S. FDA-approved cannabis-based medications contain THC. Epidiolex (cannabidiol), an oral drug that Jazz owns but that does not contain THC, is the only cannabis-derived therapy with the FDA's green light.

Jazz Pharmaceuticals took ownership of Epidiolex when it acquired GW Pharmaceuticals in February 2021. The drug is approved for patients at least one-year-old for rare diseases characterized by severe early-onset epilepsy, including Dravet Syndrome, Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex. Epidiolex also has the European Medicines Agency's approval in patients at least two years old with LGS and Dravet Syndrome.

Even with the setback with Sativex, it seems that Jazz remains on track to achieve annual revenue of $5 billion by 2025. Outlining plans in January, the company said that its acquisition of GW, the approval of Rylaze for acute lymphoblastic leukemia and the logging of $3 billion in revenue for 2021 place it in a solid position to hit profit expectations.

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