FDA Approves First Drug From Marijuana Plant

Lynette PayneJun 27, 2018

In three clinical trials covering 516 patients with either form of epilepsy, Epidiolex plus other antiepileptic medications reduced the frequency of seizures. It's not yet clear why the ingredient, known as CBD, reduces seizures in some people. 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. Nevertheless, we're encouraged that the Epidiolex approval will bring more and more research interest and funding to cannabinoid based therapies that have the potential to provide significant changes to consumers' lives.

The FDA has previously approved synthetic medications that resemble or are identical to THC. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD. Schedule 1 substances such as marijuana and heroin are considered to be the most deadly, and deemed to have no medical benefit at all. Epidiolex contains less than 0.1% of THC.

Physicians say it's important to have a consistent, government-regulated version.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections. Heather Jackson of Colorado Springs gave it to her son. At just 4 months old, he started having violent seizures.

"That lobbies heavily against any reform except for their one drug", Figi said.

Why? Because their product and company status will no longer exist in the legal gray area, and hopefully the mass confusion over which CBD products are legal and which are not will come to an end.

The immediate impact of Monday's approval on these products is unclear.

Some experts believe the anticipated approval will likely open the floodgates for product demand of other CBD products, and place further pressure on the FDA to move it along and approve other CBD-based medications.

Most CBD producers sidestep the issue by making only broad claims about general health and well-being.

The FDA seal is nonetheless seen to be a boon for the broader industry. Some parents have used unapproved CBD oils to treat their children.

Some have said that they have no intention of switching to the new prescription CBD drug because the products they're using are helping their children.

GW Pharma grows its own supply of cannabis in specialized glass houses in the United Kingdom to ensure uniformity in the genetic composition of the plants, which are then processed into a liquid solution of CBD. The company has pushed legislation in several states to make sure its drug can be legally sold and prescribed.

A total of 30 US states, the District of Columbia, Guam and Puerto Rico allow the use of medical marijuana in some form, according to the US National Conference of State Legislatures. GW won't be able to market Epidiolex until the DEA reclassifies CBD.

Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision. She's concerned about the British company, GW Pharmaceuticals, behind the new drug. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances.

The European Medicines Agency is expected to rule on the therapy in early 2019. "This is how sound medical science is advanced".

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