7. February 2012 12:39
Almirall has submitted a second wave of regulatory submissions for Sativex in Europe for the treatment of spasticity in patients with multiple sclerosis (MS).
Health Authorities in several European countries have been sent an application by GW Pharmaceuticals, under a Mutual Recognition Procedure (MRP), after the UK acted as a referencing member state.
Bertil Lindmark, Chief Scientific Officer at Almirall, says the company is “excited by this opportunity of broadening the geographical accessibility of the unique benefits of Sativex”.
Sativex, which main active ingredients are extracted from selected chemotypes of cannabis, is currently only available in Denmark, Germany, Spain, Canada, New Zealand and the UK.
Barcelona-based Almirall says the endocannabinoid system modulator offers a new therapeutic option to patients suffering from spasticity with MS who have previously failed to respond to other anti-spasticity medication.
There are approximately 500,000 people suffering from MS in the top five EU countries with spasticity occurring in as many as three-quarters of these people with the condition.
Sativex, which is administered conveniently as an oromucosal spray, provides optimal delivery and allows patients flexible doses to manage the variable nature of spasticity individually. It has been developed by GW Pharmaceuticals, and is also in Phase III clinical development for the treatment of cancer pain.