Cannabis-based drug Sativex fails latest clinical trial
Cannabis Health News
The cannabis-based drug Sativex, which is used to treat spasticity in multiple sclerosis (MS), has failed to meet its objective 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 a Phase III clinical trial, 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. READ MORE: MS patients denied access to “life-changing” cannabis drug Two additional, ongoing Phase III trials are underway which will inform a comprehensive development plan, the company said. Rob Iannone, global head of research…
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Source : Cannabis-based drug Sativex fails latest clinical trial
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