The Food and Drug Administration (FDA) have approved their first marijuana derived medication. The drug, called Epidiolex, will be used to treat two rare and severe forms of epilepsy, Lennox-Gastaut and Dravet syndromes, which start during childhood and can sometimes continue on into adulthood. The conditions affect just under 45,000 people in the U.S. and involve patients experiencing multiple seizures a day, that can cause other physical and intellectual conditions and result in accidents and even early death. Epidiolex was tested in three randomized, placebo-controlled trials that involved approximately 500 patients and was found to be effective in treating the disorders. It will be the first approved treatment for Dravet syndrome and may also be used to treat other forms of epilepsy.
A Pioneering Moment for CBD?
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb informed reporters.
Until now, the Drug Enforcement Administration (DEA) have classified marijuana as a Schedule I drug, alongside heroin and LSD. This category is used for drugs that have a high risk of abuse, have no medical purposes and are unsafe to test on humans. Given that this is the first marijuana derived drug to be used for medicinal purposes, the DEA are stating that a reclassification will happen over the coming three months; in particular as it relates to the compound in marijuana called cannabidiol (CBD).
A Non-Psychoactive Concentrated Medication
Epidiolex is made from a highly purified form of CBD, a medicinal compound found to be effective at treating pain, inflammation, seizures and more. It is a non-psychoactive compound, meaning that it does not produce a high. THC is the psychoactive compound responsible for producing the high. In the past, the FDA approved drugs that contained a synthetic form of THC in order to treat nausea in cancer patients and other conditions. This would be the first time the FDA is approving a drug that is derived from compounds directly from the plant itself.
“The DEA will need to make a different scheduling decision for CBD…because it now has an accepted medical use,” Dr. Douglas Throckmorton, deputy director of regulatory programs at the FDA’s Center for Drug Evaluation and Research told reporters.
The Push for Reform
Marijuana is legal for medical use in 29 states in the U.S. One of its main uses is in the treatment of epilepsy in children. In fact, it has been the parents of sick children who have been the loudest voices when it comes to marijuana reform. These parents have been using a variety of methods to treat children including oils, tinctures and capsules. The issue is that each method is not always consistent when it comes to dosage. Epidiolex is offering a solution to this problem.
The FDA approval of the drug is a milestone for those who have been promoting the medicinal benefits of marijuana for many years. The move may open the way for more research and new forms of therapy for treating more conditions in the future.