British biotechnology giant GW Pharmaceuticals made history by becoming the first company to obtain approval from the Food and Drug Administration (FDA) to market a marijuana-based herbal drug called Epidiolex.
The approval was already expected, after a panel of advisers from the FDA unanimously recommended its 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 of synthetic variety, not those that actually came from a marijuana plant.
Epidiolex, whose active ingredient is a formulation of the cannabidiol marijuana component (CBD), that is, not the “herb” part, THC (tetrahydrocannabinol). It was approved for children two years of age and older with certain intractable disorders of childhood epilepsy: Dravet syndrome and Lennox-Gastaut syndrome. Now that it’s done, the floodgates could be opened for other companies, and for GW Pharma itself, the company’s CEO, Justin Gover, tells Fortune.
“EPIDIOLEX CAN GET MORE INDICATIONS, MAINLY WITHIN THE SPHERE OF EPILEPSY, AS WELL AS POTENTIALLY OTHERS,” GOVER SAID IN A TELEPHONE INTERVIEW.
So, what else could be the next? GW could “start accelerating investment in other types of cannabinoids,” including another treatment in its portfolio called Sativex. That medication has actually already been approved in several countries outside the US. UU to treat spasmodic movements of muscles in patients with multiple sclerosis (MS); the firm may try to expand it to the United States now that the FDA has indicated its willingness to consider treatments derived from marijuana backed by clinical trial data.
This last point is essential for GW Pharma and its general ambitions, particularly to win over doctors who would have to prescribe cannabis – based medicines. “The fact that the Epidiolex program was designed and conceived with the medical community that wants to see real science in the field of cannabinoids” is what gives it an advantage, explains Gover.
Theoretically, several cannabinoid formulations may also be promising in the treatment of neurological and behavioral disorders.
As for the more flexible definitions of “medical marijuana” to treat pain and other conditions, it is not expected that they will still be used by the FDA. The commissioner of the agency, Scott Gottlieb, has stressed that it is necessary to conduct much more rigorous studies on the medical effects of the herb in general.