US approves Epidiolex, first marijuana-derived drug

The drug, GW Pharmaceuticals' Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high.

GW Pharmaceuticals has been working to change state drug schedules ahead of the FDA approval announcement.

On Monday the agency approved its first marijuana-derived drug, Epidiolex, for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two rare forms of pediatric epilepsy.

And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said.

Treatments available for both disorders are far from ideal and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said. With the approval, Epidiolex is expected to be available on USA markets by September and become a $1 billion-plus seller. Carreno explains it as a waterfall-type effect.

But before the medicine can hit the market in those areas, the Drug Enforcement Administration must reclassify marijuana, now a Schedule I drug, along with heroin and Ecstasy, that is described as a substance with "no now accepted medical use and a high potential for abuse". A similar descheduling occurred with Adderall, the very widely prescribed ADHD medication. What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research. As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire. Both are cannabinoids and are similar at the molecular level.

The FDA has approved synthetic versions of some cannabinoid chemicals found in the marijuana plant for other purposes, including cancer pain relief. Agency officials paved the way for the cannabis-based drug by defending its effects in a briefing document, writing, "In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders".

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", said Food and Drug Administration Commissioner Scott Gottlieb.

"I'm really happy we have a product that will be much cleaner and one that I know what it is", said Dr. Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy. Sativex hasn't been granted approval in the United States, however.

If the floodgates were to open, one issue that must be addressed is the large glut of poorly regulated products. But CBD products available in retail stores can have unreliable concentrations or poor quality controls. A published study in the Journal of the American Medical Association (JAMA) showed tremendous variability in 84 CBD products tested. The stock has run up almost 50 percent in the past 12 months.

For now, the easiest thing for consumers to remember is that CBD from hemp is legal while CBD from marijuana is not.

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