FDA Approves First Drug From Marijuana Plant

Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016

Epidiolex, made by GW Pharmaceuticals, is the first medication derived from the cannabis plant ever approved by the FDA.

While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case.

The government agency gave the green light this week to an oral solution called Epidiolex to treat Lennox-Gastaut syndrome and Dravet syndrome in those ages 2 and up. In clinical trials, patients administered Epidiolex, on average, obtained a 40 percent reduction in seizure frequency.

"The FDA will continue to support rigorous scientific research on potential medical treatments using marijuana and its components that seek to be developed through the appropriate scientific channels", FDA Commissioner Scott Gottlieb said in a Monday press release.

"This is an important medical advance".

Gottlieb noted that the action was "not an approval of marijuana or all of its components" but rather of one specific CBD medication for a particular use.

"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life", said Billy Dunn, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. Epidiolex's approval also marks the first time the FDA has approved a drug to treat Dravet syndrome. The agency is expected to make this classification within 90 days.

US health regulators have approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law. Cannabis-derived CBD products are available where recreational marijuana is sold, though CBD derived from industrial hemp faces fewer regulations and is even stocked by some grocery stores. It is currently a Schedule 1 drug, along with heroin, because of abuse potential, but GW expects Epidiolex to have a less restrictive DEA scheduling because of studies showing minimal abuse potential and now an approved medical use.

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

Called Epidiolex, the drug is created to treat two rare forms of childhood epilepsy using a cannabis compound called cannabidiol (or CBD). From Walmart to CVS to the Mom-n-Pop drugstores still kicking it Smalltown, USA - legitimate cannabis medicine will be available in the same way as other prescription drugs. Some parents have used unapproved CBD oils to treat their children. "This new treatment provides new options for patients".

Ironically, an advisory panel for the FDA unanimously approved the recommendation for Epidiolex one day before 4/20. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

GW Pharma won't be able to launch the drug right away, however, because its active ingredient, CBD, needs to be rescheduled by the DEA. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder.

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