FDA Approves Medicine Containing Cannabis for the First Time

The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year. Epidiolex contains CBD, a cannabis chemical compound skyrocketing in popularity and driving what is estimated to have doubled into a $200 million market in 2018.

A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program. But it could end up changing state laws in such a way that all CBD products must get FDA approval before they're sold.

Ohio's medical marijuana program was expected to be operational in early September but now has no definite start date, and none of the approved cultivation centers has begun growing the plant. Any drug containing cannabis from here on out will still need to clear plenty of hurdles before getting approval.

Proponents of medical marijuana have heralded the substance as the "answer to the opioid crisis" for relieving chronic pain with nonfatal side effects. "I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults". As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire.

Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effects and has been cited by scientists as a potential treatment for mental health issues.

FDA's Gottlieb warned about the use of CBD products with "unproven medical claims".

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Although several states have legalized the medical and recreational use of marijuana, the federal agency had yet to do so until today.

"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. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy. "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".

GW Pharmaceuticals grows the plants in the United Kingdom. Others said they are anxious to try an FDA-approved product. That decision is expected within 90 days.

A new drug derived from marijuana just became the first of its kind to get the green light from the U.S. government.

For those who have long argued that cannabis offers medical benefits, the FDA approval represents a milestone, "a recognition that the plant is a rich source of compounds which have potential therapeutic activity", Justin Gover, chief executive of GW Pharmaceuticals, the London-based company that developed the drug, said in an interview last week.

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