By Steve Elliott
Big Pharma giant GW Pharmaceuticals has submitted an application seeking to expand marketing authorization for Sativex into France for the treatment of spasticity due to multiple sclerosis (MS).
Sativex, an oral spray containing a 50:50 mixture of the cannabinoids THC (tetrahydrocannabinol) and CBD (cannabidiol), is already approved as a treatment for MS spasticity in 21 countries, including 17 countries in Europe. The medicine is available on prescription in the United Kingdom, Spain, Germany, Canada, Denmark, Norway, Israel, Austria, Poland, Sweden and Italy, with launches in preparation in eight more European countries, as well as Australia and New Zealand, according to GW.
"Sativex meets a significant unmet medical need for patients with multiple sclerosis and we look forward to working with the French authorities so as to allow this important medicine to be made available in France," said Justin Gover, chief executive officer at GW Pharmaceuticals.
"The submission of this MRP for Sativex in France builds on the recent commercial launch in Italy and continues the momentum of expanding Sativex availability throughout Europe," Gover said. "We see this growth as important validation of patient and physician acceptance of Sativex in meeting the needs of people with multiple sclerosis."