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A recently completed phase III trial has demonstrated the ability of Sativex, a cannabis extract, to reduce the severe spasticity associated with multiple sclerosis (MS). Reports indicate that Sativex was successful in reducing spasm frequency, overall spasticity scores, and sleep disturbance related to spasticity. The drug is currently approved for treatment of multiple sclerosis in Europe and Canada, but not in the U.S. In the U.K. and Spain, its use is limited to only those patients who have not responded to other medication.
Sativex is also undergoing phase III clinical trials in the U.S. for the treatment of severe neuropathic pain and cancer pain. It is already approved in Canada for severe neuropathic pain due to multiple sclerosis (MS) and as an adjunct to opioid therapy in patients with advanced cancer. The drug is believed to act via cannabinoid receptors in the CNS and in immune cells. Activation of these receptors within the pain pathways is known to reduce pain in relevant pain models. Side effects included nausea, fatigue, and dizziness which were rated mild to moderate. There is no evidence of a euphoric effect that is associated with marijuana use. It has a unique method of administration which consists of a metered dose spray under the tongue or inside the cheek. Sativex is produced by GW pharmaceuticals of the U.K. and will be marketed in the U.S. by Novartis. We may see Sativex available for management of severe pain and MS related spasticity in the U.S. possibly as soon as next year.
For more information on Sativex Trials CLICK HERE
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