FDA has just approved a marijuana-based epilepsy drug

On Monday, the US Food and Drug Administration made a startling announcement: The agency had recommended for approval the first marijuana drug, called Epidiolex, to treat two types of severe epilepsy.

Epidiolex is an oil containing cannabidiol (CBD) – a component of cannabis that does not cause the psychoactive peak usually badociated with marijuana. The drug has been officially approved to treat Lennox-Gastaut syndrome and Dravet syndrome, which are particularly rare. Both cause daily convulsions, are badociated with developmental delays, and often do not respond to standard anti-epileptic drugs. In three randomized controlled trials, which included more than 500 patients with one of two syndromes, Epidiolex reduced seizure frequency when compared to placebo when it was added to the patient's usual regimens.

Like all marijuana components, CBD is still clbadified as an Schedule I drug by the Drug Enforcement Administration, which means that it is considered by this agency as n & # 39; having no medical use. Possession is illegal at the federal level, and its legal status in many states is murky. Epidiolex can not be sold to patients until this designation is changed, and since the FDA has reported that the compound has, in fact, medical use, this should happen.

GW Pharmaceuticals, which developed the drug, said a press release that it expects the compound to be reported by the DEA within 90 days. It is not clear, however, what the new CBD clbadification will be changed.

FDA Commissioner Scott Gottlieb pointed out in an FDA statement that the decision is not an endorsement of the medical use of marijuana as a whole. "It's the approval of a specific CBD drug for a specific use," he said in the statement.

Once the drug reaches the pharmacy shelves (and baduming that CBD is removed from the list of drugs in Schedule I), patients with Lennox-Gastaut syndrome and Dravet syndrome will not be the only ones to benefit. Epidiolex will presumably be prescribed for other forms of epilepsy, experts say – and potentially other disorders too,

Most importantly, the anticipated rescheduling of the CBD will allow researchers to study more easily its effectiveness for other diseases.

Right now, however, scientists are hoping to study the effects of CBD on a number of medical conditions that must go through dozens of cycles with the FDA, the DEA, and the National Institute of Medicine. drug abuse. difficult to build a sustained research dynamic. But the studies that exist are promising: they suggest that CBD has anti-inflammatory properties and helps relieve anxiety. It is also a potential therapeutic target for the disorder of opioid use and addition.

The expected rescheduling of the CBD will make it easier to resolve the remaining questions about the efficacy, side effects, and doses of the compound, said Diana Martinez, professor of psychiatry at Columbia, at the Daily Beast. Martinez is in the early stages of a CBD screening study as a treatment for nerve damage pain caused by chemotherapy, and had to through the existing process.

"It's unfortunate, it's really hard," Martinez said. "The movement with the DEA and with the FDA will make our life easier.If cannabidiol is eliminated from Schedule I, much more research will be able to take place."

When a new drug is approved by the FDA, the company that underlies it has the right to advertise and market its product only for a specific use that the agency has approved for. However, Once Epidiolex is on the market, doctors may choose to prescribe this drug off-label, for other diseases that they determine that it would be able to treat. Tim Welty, Professor of Pharmaceutical Practice at Drake University, said that is probably what will happen with Epidiolex. "It is almost certain that doctors prescribe the drug off-label," he said. to The Daily Beast

It is difficult to predict what doctors could prescribe and at what frequency "It will probably not be the first medication they are turning to for other forms of epilepsy," Welty said. "The doctors I know and speak of treat this as just another drug to consider, not as a first-line drug. It's probably a third- or fourth-line drug in patients who have failed other treatments, "he said.

But the pharmaceutical nature of the product makes Epidiolex a safer and more controlled way of taking CBD Since most CBD products are commercially available, the concentrations of the compound indicated by the product are often incorrect. JAM A about 70% of products sold online are mislabeled.

"There is no control, and you really do not know what you're getting," Welty said. However, epidiolex is an approved and FDA approved form of the compound, monitored and monitored in the same manner as any other drug.

"If you have a group of people who have been interested in CBD but have been reluctant to use the products available, there is now an approved product," Welty said.

The Epidiolex is not expected to significantly reduce the activity of existing dispensaries that sell CBD products derived from marijuana. Kevin Hill, Addiction Psychiatrist and Director of the Addiction Psychiatry Division at the Beth Israel Deaconess Medical Center, told The Daily Beast that he does not expect people who already use CBD treat diseases and conditions to ask their Epidiolex doctors en mbade. Even though the price has not yet been set, the drug will likely be expensive, Hill said, and he does not expect that they will adopt a drug that requires it. approval of a doctor.

This is because people already have easy and cheap access to CBD. It is already used for problems like anxiety and pain in states with legal medical laws on marijuana.

Physicians, however, are generally cautious in prescribing or recommending the compound for the range of disorders for which they are already using the product. Having approved this, I still think doctors will be hesitant, "said Hill.It is because, despite his popularity, there is still not enough evidence to support the use of CBD for something other than epilepsy.Having a drug on the market, however, can lead to more conversations between doctors and patients about the problems and complaints that they are interested in CBD. " CBD may not be the best option, but having this conversation means that the patient is more likely to get help, "he said.

Yet when choosing between drugs demonstrating a particular use and compounds such as CBD, which are more speculative, the evidence-based approach should be used first.

"Sometimes people exhaust their options. But we need to base initial care on clinical evidence, "Hill said." We need to pursue studies rigorously designed for other uses of CBD. "

Martinez would like to see more studies on Anti-inflammatory properties of CBD, and its potential to treat diseases such as rheumatoid arthritis and irritable bowel syndrome.For Hill, chronic pain and opioid use disorder are at the top of the list. Epidiolex's endorsement is a step in the right direction towards a more CBD-based approach, he said. "This gives credence to the idea that cannabinoids can be effective treatments. . "