Sativex is an endocannabinoid modulator made of two actives – THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol).
It was developed and is manufactured by GW Pharmaceuticals.
GW Pharmaceuticals’ marketing partner Almirall holds marketing rights in Europe (except UK).
Besides the Czech Republic, the countries involved in the MRP were Germany, Italy, Denmark, Sweden and Austria.
Launch timing in each country will be dependent on national regulations concerning pricing and reimbursement.
Almirall anticipates launch in Germany, Denmark and Sweden before the end of 2011 with the remaining countries, including the Czech Republic, expected in 2012.
Sativex is also in phase III clinical development for the treatment of cancer pain.