A treatment for multiple sclerosis (MS) spasticity has been granted national reimbursement in Spain.
GW Pharmaceuticals has announced that the Spanish Ministry of Health will reimburse use of Sativex®, which is expected to be launched in Spain shortly by GW’s marketing partner Almirall, S.A. (ALM).
This is the first specific treatment for spasticity associated with MS that will shortly be available in the Spanish hospital pharmacies.
It is the first treatment specifically designed for patients withMS-related spasticity who have not responded to other treatments.
Sativex is administered as an oral spray, enabling flexible dosage,which is particularly appropriate given the variable nature ofspasticity and MS itself.
Approval of Sativex® in additional EU member states is expected in 2011
It is estimated that there are around 40,000 people suffering from MS in Spain of whom around 75% suffer from spasticity, a painful and debilitating disorder that causes stiffness in muscles, painful cramps and sudden uncontrolled movements in limbs (spasms) that increase tiredness and reduced mobility.
Even daily activities such as unscrewing a bottle top or getting out of bed can become difficult, affecting the patients’ quality of life and state of mind.
Sativex is an endocannabinoid system modulator made up principally of two active ingredients -THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol)-, and developed by GW Pharmaceuticals (UK).
The Phase III programme for Sativex® in cancer pain started late 2010.
Almirall, S.A. has the marketing rights in Europe (except the UK).
This is the first prescription medicine approved in Spain derived from cannabis and will be available with full reimbursement to MS patients in hospitals.