The following list provides some of the major pharmaceuticals related to cannabis that have been developed or are currently being developed. Sativex (nabiximols) is a cannabis plant–based medicine from GW Pharmaceuticals that has been approved in twenty-four countries (excluding the United States), at press time, for multiple sclerosis and for muscle spasticity.
The formula includes a 1:1 equal ratio of THC to CBD and comes as an oromucosal spray. It was approved and launched in the United Kingdom in 2010 as the first cannabis-based prescription medicine in the world. In the United States, Phase III clinical trials started in late 2006 for treatment of pain in cancer patients, and in 2011 a U.S. patent was granted for Sativex for cancer pain.
In 2014 the FDA granted “fast track” designation to Sativex for the treatment of pain in patients with advanced cancer. 152 Epidiolex (cannabidiol) is a plant-based, oral pharmaceutical formulation of pure CBD, made by GW Pharmaceuticals, which is in development for the treatment of a number of rare childhood-onset epilepsy disorders.
GW has conducted extensive pre-clinical research of CBD for epilepsy since 2007. This research has shown that CBD has significant anti-epileptiform and anticonvulsant activity, using a variety of in vitro and in vivo models, and reduced seizures in various acute animal models of epilepsy. To date, GW has received orphan drug designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, tuberous sclerosis complex, and infantile spasms.
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Additionally, GW has received fast track designation from the FDA and orphan designation from the European Medicines Agency for Epidiolex for the treatment of Dravet syndrome.
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GW is currently evaluating additional clinical development programs in other orphan seizure disorders.
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