The CEO behind the first prescription marijuana drug explains what the move means for the future of cannabis-based medicine
- Monday was both a milestone and a jumping off point for the CEO of GW Pharmaceuticals, whose medicine just became the first marijuana-derived drug to win federal approval.
- Gover said the green light signifies that a solid approval pathway is starting to take shape for drugs derived from cannabis.
- "This signals that cannabinoid science has arrived," Gover told Business Insider.
Monday was both a milestone and a jumping off point for Justin Gover, CEO of a company that makes Epidiolex, a medicine that just became the first marijuana-derived drug to win federal approval.
Made by GW Pharmaceuticals, the drug treats two rare types of epilepsy using CBD, a therapeutic compound in cannabis that's not linked with a high. Gover said the green light signifies that his company's recent efforts in developing more drugs from marijuana's compounds (also known as cannabinoids) finally have a concrete path forward.
"This signals that cannabinoid science has arrived," Gover told Business Insider.
Still, making drugs from marijuana is no small feat. The Drug Enforcement Administration keeps a tight lid on the plant. As part of an umbrella prohibition on cannabis, each and every compound in the plant is currently classified as having "no recognized medical use."
That may be slowly changing, starting with Epidiolex. As of yesterday's approval from the Food and Drug Administration, the DEA has 90 days to put the drug's active ingredient, CBD, in a distinct category - separate from marijuana - so that doctors can prescribe it.
'The FDA can and will approve cannabinoid-based medications'
The FDA's green light on Epidiolex, coupled with the DEA's reclassification of CBD, could have big implications for the future of cannabis-based medicine.
One key takeaway is that other drugs made with CBD now have a clearer path forward for federal approval.
But the move means that other drugs made from other marijuana compounds, like THC, could potentially follow in Epidiolex's footsteps.
"This hits home at the reality that the FDA can and will approve cannabinoid-based medications that meet the standards of quality, safety, and efficacy," Gover said.
That means that - just as with any other drug - as long as pharmaceutical companies can demonstrate they've subjected a marijuana-derived candidate to large, well-designed clinical trials, it has a fair chance of being seriously considered for approval by the FDA. This might involve designing robust clinical trials, partnering with top university researchers, and presenting strong data - all of which GW Pharmaceuticals did in the years leading up to Epidiolex's recent green light.
Now that one CBD-based drug is in the bag, GW is exploring several other applications for the drug. The company is also looking beyond CBD at uses for marijuana compounds that range from neurological conditions to diseases like multiple sclerosis and cancer to other issues like pain.
"While these areas are at an earlier stage of development, the evidence we have, it's very much a science-led program," Gover said. "There's promising early stage evidence here and it certainly warrants more formal investigation."
Making drugs from marijuana is complex, but doable
While GW waits for the DEA has to reclassify CBD so that doctors can prescribe Epidiolex, other drug-makers have been finding creative ways around the federal government's tight leash on marijuana.
Chicago-based Abbott Pharmaceuticals spinoff AbbVie sources the THC in nausea drug Marinol from a lab, for example, and Johnson & Johnson is teaming up with Canadian marijuana startups to help get their work on a range of applications off the ground.
Small pharmaceutical companies, on the other hand, are applying for federal permits to import cannabis extracts just so they can study them in clinical trials.
While many of these developments remain in the early stages, the FDA's Epidiolex decision points to at least one concrete path ahead.
"After 20 years of researching cannabinoids, it [was] a historic day," Gover said.
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