GW Pharmaceuticals (LON:GWP) is prepared to launch its Sativex treatment for multiple sclerosis in Germany this July after the country’s health authorities granted regulatory approval for the treatment. Sativex is already available for MS patients in the UK and in Spain.
The medicine is a first-in-class ‘endocannabinoid’ (cannabis-based) system modulator for the treatment of spasticity in MS. It is delivered by a spray that can be delivered into the mouth either onto the inside of the cheek or under the tongue.
Spasticity (also known as muscle stiffness) has a negative impact on patients’ daily lives as it reduces their capacity to carry out everyday activities such as walking and keeping upright, as well as having an impact on their general mobility, bladder function and quality of sleep.
According to GW Pharma, around half of people with MS do not manage to find relief from these symptoms with currently-available treatments.
The firm says that evidence generated from clinical trials shows that Sativex has a positive impact on spasticity in MS, while alleviating associated symptoms.
“Having recently successfully launched Sativex in Spain, we are very pleased to have now received regulatory approval in Germany,” said Justin Gover, GW Pharma’s managing director. “Germany has the largest MS population in Europe and we look forward to offering people with MS in Germany the opportunity to benefit from Sativex as a new first in class treatment to treat their spasticity.”
The approval of the medicine in Germany follows the successful completion in March this March of the European Mutual Recognition Procedure (MRP) with all six countries involved – Germany, Denmark, Sweden, Italy, the Czech Republic and Austria – recommending approval. GW Pharma plans to make a further MRP submission later this year in order to expand the approval of Sativex.
GW Pharma’s share price was up 0.2 per cent at midday today at 120.25 pence.