Cannabis-Based MS Medicine Nearing Approval in UK, Spain
A cannabis-based medicine that is used in the treatment of multiple sclerosis could be approved in Spain and the UK by the second quarter of this year.
GW Pharmaceuticals, the producers of the drug Sativex, told Reuters reporter Ben Hirschler that regulatory committees in both countries found no serious quality or safety issues with the medication, which is used to relieve neuropathic pain and muscle stiffness in MS.
“Once the regulators have agreed final wording on the patient leaflet, the decentralised procedure can close and the process will enter its final phase,” the company reports in a March 18 regulatory update, posted on their official website. “This final phase, known as the national phase, takes place separately in the UK and Spain and its purpose is to finalise local wording on product packaging and related documents.”
The drug, which is currently available in Canada, will likely be cleared for release in the two European countries once issues with the patient information leaflet can be ironed out. Sativex can also be used in the treatment of pain in cancer patients, and is currently undergoing clinical trials in the United States, where it will be released for that purpose.
“This is a major milestone in the regulatory process for Sativex, and for GW’s future prospects,” the company’s director of research and development, Dr. Stephen Wright, said as part of the regulatory update statement. “We look forward to working with the regulators towards a successful completion of this process and to supporting our marketing partners as they prepare for product launch. This progress with Sativex also provides further validation of GW’s cannabinoid platform and the significant long term promise of GW’s portfolio of cannabinoid medicines.”










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