Therapy is for the treatment of spasticity due to multiple sclerosis
Jazz Pharmaceuticals has announced that Sativex – also known as nabiximols – has been accepted by the Scottish Medicines Consortium (SMC) for use by NHS Scotland as a treatment for symptom improvement in adult patients with moderate-to-severe spasticity due to multiple sclerosis (MS).
It also involves individuals who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy.
Sativex is a complex botanical formulation that contains the principal cannabinoids THC and CBD in addition to specific minor cannabinoids and other non-cannabinoid components.
The decision recommends that nabiximols is made available for routine reimbursement across Scotland – the second UK nation to do so, following the recommendation by the National Institute for Health and Care Excellence (NICE) for England in 2019.
Nabiximols was also approved by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for use as a treatment of spasticity due to MS in 2010. The therapy was first approved by Health Canada in 2005 and has since been approved in 29 countries under the trade name Sativex.
“This is an important decision by the SMC and an exciting development for patients and their families impacted by this difficult to treat condition,” reflected Samantha Pearce, senior vice president at Jazz Pharmaceuticals.
“We are delighted that the SMC have recognised the evidence base for Sativex. This underscores the importance of randomised clinical trials and regulatory approval in providing access to cannabis-based medicines to patients in need.”
MS is a chronic neurological condition characterised by progressive and disabling loss of motor and sensory nervous system functions, and is most commonly diagnosed between the ages of 20 and 40 years old. In the UK, it is estimated that 130,000 people have MS and an estimated 16,000 people with MS live in Scotland, representing a significantly higher incidence rate of 290 per 100,000 in the population.
MS spasticity is characterised as increased resistance in muscle movement resulting in more rigid muscles than normal, this affects up to 84% of MS patients across their disease evolution. The condition can also lead to pain, sexual dysfunction, dysarthria, fatigue, depression and anxiety, mobility impairment, bladder and bowel dysfunction, and sleep disturbances.
Nabiximols was developed by GW Pharmaceuticals and, following the acquisition of GW by Jazz Pharmaceuticals in 2021, forms part of the company’s GW Cannabinoid Platform.
