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Jazz Pharmaceuticals obtains SMC approval to reimburse Sativex

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Treatment is the treatment of spasticity caused by 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 to improve symptoms in adult patients with moderate to severe spasticity due to multiple sclerosis (MS). ).

It also includes individuals who have not responded adequately to other anticonvulsant medications and who show clinically significant improvement in seizure-related symptoms during the initial treatment trial.

Sativex is a complex plant-based formula that contains the major cannabinoids THC and CBD as well as specific secondary cannabinoids and other non-cannabis ingredients.

The decision recommends making nabiximols available for routine reimbursement across Scotland – the second British country to do so, following a recommendation from 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 for spasticity caused by MS in 2010. The treatment 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 from SMC and an exciting development for patients and their families who have been affected by this hard-to-treat condition,” reflected Samantha Pearce, senior vice president at Jazz Pharmaceuticals.

“We are pleased that SMC has recognized Sativex’s evidence base. This underscores the importance of randomized clinical trials and regulatory approval in providing access to cannabis-based medicines for patients in need.”

MS is a chronic neurological condition characterized by progressive and disabling loss of sensory and motor nervous system function, most commonly diagnosed between the ages of 20 and 40. In the UK it is estimated that 130,000 people have MS and an estimated 16,000 people live with MS in Scotland, which represents a much higher incidence rate of 290 per 100,000 population.

MS is characterized by increased resistance in muscle movement resulting in more muscle stiffness than normal, and this affects up to 84% of MS patients through the progression of their disease. The condition can also lead to pain, impotence, dysphasia, fatigue, depression, anxiety, impaired movement, bladder and bowel dysfunction, and sleep disturbances.

Nabiximols was developed by GW Pharmaceuticals, and after Jazz Pharmaceuticals acquired GW in 2021, it became part of the company’s GW Cannabinoid platform.

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