The cannabis-based drug Sativex, which is used to treat spasticity in multiple sclerosis (MS), has failed to meet the primary end point in a recent clinical trial.
Sativex, the cannabis-based medicine which is prescribed on the NHS to treat spasticity in multiple sclerosis (MS) patients, has failed to meet its main objective in the first of three Phase III clinical trials, a statement from producer Jazz Pharmaceuticals has revealed.
The Nabiximols THC:CBD spray was developed by GW Pharmaceuticals, the producer of Epidiolex, which was bought by Jazz Pharma for $7.2 billion last year.
It was approved for use to treat moderate to severe spasticity in MS patients by the National Institute for Health and Care Excellence (NICE) in 2018.
In total, the drug has been approved in 29 countries for the treatment of adult patients who have not responded adequately to other anti-spasticity medication.
These latest results have stalled the company’s plans to expand the drug to the US.
Phase III clinical trials are designed to compare the safety and effectiveness of the new treatment against the current standard treatment.
RELEASE MSS1 was the first, and smallest, of three clinical trials in the current programme. It evaluated the safety and efficacy of Sativex in 68 patients with MS spasticity.
According to the statement, the trial did not meet the primary endpoint of change in the lower limbs, between baseline and day 21, as measured by the modified Ashworth Scale (MAS) – a muscle tone assessment scale used to assess the resistance experienced during passive range of motion.
The primary endpoint of change, is the most important outcome and is used to assess the primary objective of a trial.
Two additional, ongoing Phase III trials are underway which will inform a comprehensive development plan, the company said.
Rob Iannone, global head of research and development at Jazz Pharmaceuticals, commented: “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 US FDA New Drug Application submission.
“I would like to extend a heartfelt thank you to all those who supported and made this study possible, including the patients who were enrolled, their families, our investigators, staff, and all of the dedicated Jazz employees.”
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