A new medicine that many are still considering to be in its experimental stages could potentially be the first drug made from the cannabis plant that would receive a boost from the Food and Drug Administration staff.
The drug has been created and manufactured by the U.K. company GW Pharmaceuticals, one of the big players in the cannabis industry. The medication is currently set to help treat seizures in two rare forms of epilepsy that mostly affect children. The medication does reportedly have an increased risk in liver injury, but this seems to be extremely minimal.
The staff at the FDA have been showing their commitment to making this drug pass through their rigorous testing which is unusual for the agency. The staff stated that “the risk-benefit profile established by the data in the application appears to support approval of cannabidiol.” After this announcement was made, the GW Pharma American depositary receipts rose by as much as 4.5% to $126 during the early part of the trading day.
The drug is manufactured from the marijuana plant, and specially the component known as cannabidiol or CBD. CBD has been researched heavily over the past few years and continues to show promise in treating a wide variety of different diseases across the board. The chemical CBD is also very different from that of THC, the main psychoactive component in the cannabis plant. Unlike THC, CBD does not get the user high, which continues to help its efficacy as a treatment for children.
The treatment is known as Epidiolex, and has been around for quite some time, but only recently has this amount of support been shown for the drug by the FDA. Justin Gover, the CEO of the company stated that the drug is made from a cannabis plant that is bred specifically for the medicine to have the highest CBD content with a low THC content. The chemical is then purified and made into a strawberry-flavored oral solution. If approval of the drug is made, it would not only help the whole of the medicinal industry on cannabis, but it would be a giant leap forward in the notion of cannabis. He stated that “epidiolex, if approved, will mark a sea change in the acceptability of cannabinoids as therapy.”
Thus far, twenty nine states and the District of Columbia have passed laws in favor of medicinal marijuana with a few of the passing laws for the use of recreational cannabis. The company is working to sell the treatment as an oral solution that will treat two kinds of epilepsy. The first is known as Lennox-Gastaut and the other is Dravet syndrome. These conditions are most notably found in children, and are usually resistant to many treatments. Sadly, around 20% of children with Dravet syndrome die before they are able to get out of childhood, but this could be changing soon with the introduction of this new medicine.
The FDA has thus far approved only a handful of drugs made from synthetic cannabinoids, but this would mark the first time that a drug actually derived from the cannabis plant would make it through the FDA regulations. The agency will be looking at whether or not they will approve the drug as soon as June 27th, but they will also be discussing the drug this Thursday to see about whether or not it can be a valid treatment for these conditions. With the world of cannabis often seeing ups and downs, the passing of this drug through the FDA standards will likely mark a new time in the world of marijuana.
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