pharmatimesMarch 06, 2020
GW Pharmaceuticals has regained the rights to the commercialisation of Sativex (nabiximols) in the UK, taking the reins back from Bayer.
The drug, which is a complex botanical formulation that contains the principal cannabinoids THC and CBD as well as specific minor cannabinoids and other non-cannabinoid component, is indicated for spasticity due to multiple sclerosis.
Since the treatment was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in 2010, Bayer held the rights the rights to the marketing in the UK. However, under the terms of the new agreement, after December 31 2020, GW will take over all responsibilities in the UK.
In November last year, The National Institute for Health and Care Excellence (NICE) recommended the cannabidiol for the indication, after it was deemed clinically and cost effective at its current list price.
The organisation also also updated the MS Guideline to state that Sativex should be offered to treat spasticity in people with the disorder.
The med has been approved for use in the United Kingdom since June 2010 for the treatment of some symptom improvement in adult patients with moderate to severe spasticity due to MS.
MS affects approximately 100,000 people in the UK with spasticity a common symptom and major contributor to disability. Spasticity can range from mild muscle stiffness to severe, painful and uncontrollable muscle spasms, and as a consequence an individual may have difficulty in walking, picking up objects, washing, dressing and other everyday activities involving movement.
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