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The British Giant Biotechnology giant GW Pharmaceuticals entered history by becoming the first company to obtain approval from the Food and Drug Administration [FDA] to market a herbal medicine of marijuana, named Epidiolex .
Approval was already awaited, after a group of FDA advisers unanimously recommended regulatory approval in April; even so, it was an event at the federal level. Until this week, the only existing (legal) prescription treatments involving cannabis were synthetic, not those that actually came from a marijuana plant .
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Epidiolex of which active ingredient is a cannabis component of cannabidiol (CBD) that is, not the "grass" part, THC (tetrahydrocannabinol). It has been approved for children two years of age and older with certain refractory disorders of infantile epilepsy : Dravet syndrome and Lennox-Gastaut syndrome. Now that this is done, the gates could be opened for other companies, and for GW Pharma himself, the CEO of the company, Justin Gover, says Fortune. " ] Epidiolex may obtain more indications, mainly in the area of epilepsy, as well as potentially others," said Gover in a telephone interview.
So, what else could be next? GW could "start accelerating investment in other types of cannabinoids," including another treatment in his portfolio called Sativex. This drug has already been approved in several countries outside the United States USA to treat spasmodic muscle movement in patients with multiple sclerosis (MS); the company could try to expand it to the US now that the FDA has indicated that it was willing to consider marijuana-derived treatments supported by test data
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This last point is critical for GW Pharma and its general ambitions, particularly for to win doctors who should prescribe drugs based on In cannabis . "The fact that the Epidiolex program was designed and designed with the medical community that wants to see real science in the field of cannabinoids" is what gives it an edge, says Gover.
Theoretically several formulations of cannabinoids may also be promising in the treatment of neurological and behavioral disorders.
With respect to more flexible definitions of "medical marijuana" to treat pain and other conditions should not yet be used by the FDA. The commissioner of the agency, Scott Gottlieb, pointed out that it is necessary to conduct much more rigorous studies on the medical effects of the herb in general.
By Sy Mukherjee
By means of: Fortune in Spanish
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