United Kingdom (Commonwealth Union)_ Sativex, commonly known as nabiximols, has been approved by the Scottish Medicines Consortium (SMC) for use by NHS Scotland as a medication for symptom relief in multiple sclerosis (MS) patients with moderate-to-severe spasticity, according to Jazz Pharmaceuticals. Individuals who have not responded effectively to previous anti-spasticity medications and who have shown clinically meaningful improvement in spasticity-related symptoms during an initial trial of treatment are also included.
Sativex is a complex botanical formulation containing the major cannabinoids THC and CBD as well as certain minor cannabinoids and various non-cannabinoid components. The conclusion recommends that nabiximols be made routinely reimbursable in Scotland, making it the second nation in the United Kingdom to do so, following the 2019 proposal by the National Institute for Health and Care Excellence (NICE) for England. In 2010, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) also authorized nabiximols for the treatment of MS-related spasticity. Health Canada authorized the treatment for the first time in 2005, and it has subsequently been licensed in 29 countries under the brand name Sativex.
According to Samantha Pearce, senior vice president at Jazz Pharmaceuticals, this is a major decision by the SMC and an exciting breakthrough for patients and their families affected by this tough to treat illness. “We are delighted that the SMC has recognised the evidence base for Sativex. This underscores the importance of randomized clinical trials and regulatory approval in providing access to cannabis-based medicines to patients in need,” she said.
MS is a chronic neurological disorder characterized by gradual and severe loss of motor and sensory nervous system capabilities. It is often diagnosed between the ages of 20 and 40. According to estimates, nearly 130,000 people in the United Kingdom have MS, of which around 16000 people with MS reside in Scotland, reflecting a much higher incidence rate of 290 per 100,000 people.
