On Monday, GW Pharmaceuticals made history by becoming the first company to ever win Food and Drug Administration (FDA) approval for a marijuana plant-based prescription drug, dubbed Epidiolex. The approval was widely expected after a panel of FDA advisers unanimously recommended its regulatory clearance back in April; still, it was a milestone on the federal level. Until this week, the only existing (legal) prescription treatments involving cannabis were of the synthetic variety, not those that actually came from a marijuana plant.
Epidiolex, whose active ingredient is a formulation of the marijuana component cannabidiol (CBD)—i.e., not the high-causing “THC” part of weed—was approved for children two years of age and older with certain intractable childhood epilepsy disorders called Dravet syndrome and Lennox-Gastaut syndrome. Now that it’s done, the flood gates could open for other companies in the cannabis space—and for GW Pharma itself, the company’s CEO Justin Gover tells Fortune.
“Epidiolex can get more indications, primarily within the epilepsy sphere, as well as potentially other indications,” Gover said in a telephone interview. So what else might be next? GW could “start to accelerate investment in other types of cannabinoids,” including another treatment in its pipeline called Sativex. That drug has actually already been approved in several countries outside the U.S. to treat spastic muscle movements in multiple sclerosis (MS) patients; the firm may try and expand it into America now that the FDA has signaled a willingness to consider marijuana-derived treatments that are backed up by clinical trial data.
That latter point is critical to GW Pharma and its overall ambitions, particularly winning over the doctors who would have to prescribe the company’s cannabis-based medicines. “The fact that the Epidiolex program was designed and conceived with the medical community wanting to see real science in the field of cannabinoids” is what gives it a leg up, Gover explains. Theoretically, various cannabinoid formulations could also show promise in treating neurological and behavioral disorders.
As for looser definitions of “medical marijuana” to treat pain and other conditions? Don’t expect a blessing from the FDA anytime soon—agency commissioner Scott Gottlieb has stressed that far more rigorous studies need to be done on the medical effects of weed at large.
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