Sativex, a cannabidiol and delta 9 tetrahydrocannabinol product, has been granted a Fast Track designation by the FDA. In the US, over 400,000 people have either cancer pain uncontrolled with chronic opioid therapy or negative side effects from those opioids. Manufacturer GW Pharmaceuticals’ CEO Justin Glover says it’s “fully committed to delivering the first FDA-approved cannabinoid medication for these patients who currently have nowhere else to turn.”
Many patients with advanced cancer pain suffer inadequate analgesia, an unmet medical need. Medications that these needs, or treat serious or life-threatening conditions may be put on the Fast Track for development, review, and potential approval, all to get to the patient sooner. Sativex is manufactured by GW Pharmaceuticals in collaboration with Otsuka Pharmaceuticals. Currently in Phase 3 clinical trials in the US, Sativex is already used in Europe and other countries to treat multiple sclerosis induced spasticity.
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Posted on April 30, 2014