Based on the potential for abuse, the Drug Enforcement Administration (DEA) categorizes chemicals into five schedules, with Schedule 1 substances - like marijuana and heroin - considered the most deadly, and deemed to have no medical benefit whatsoever.
Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy. The family moved to Colorado in 2014 to take advantage of that state's more advanced medicinal marijuana program.
GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy. "And the FDA is committed to this kind of careful scientific research and drug development", Gottlieb concluded. On the other hand, CBD derived from cannabis is a schedule I drug, and only 28 states and Washington, DC have so far legalized it; 15 states have only legalized CBD by itself.
CBD oil is now sold online and in specialty shops across the USA, though its legal status remains murky. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters.
"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said.
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Justin Gover, chief executive officer of GW Pharmaceuticals, described the approval in the statement as "a historic milestone". Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications.
The drug, Epidiolex, is derived from cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.
Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.
Epidiolex will be marketed by Greenwich Biosciences, a subsidiary of GW Pharmaceuticals. "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery".
Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA. The FDA is willing to help companies that want to pursue such research programs, he said, but they need to prove their products work and are safe with data from clinical trials.