A revolutionary move by The Federal Drug Administration, the FDA approves of the first plant-based marijuana medicine Epidiolex. This essentially opens up the possibilities in the future for medical marijuana for treatment for conditions like epilepsy.
Does CBD Oil Help Epilepsy?
Epidiolex is made from CBD extracted from marijuana to treat certain forms of epileptic seizures. CBD is simply a cannabinoid that does not get you high. Epidiolex is used in patients 2 or older that struggle with rare and severe forms of epilepsy, like Lennox Gastaut Syndrome and Dravat syndrome. This is the first time a drug to help with Dravat syndrome has been approved.
The decision was passed Monday, June 25th, but only a handful of states will dispense the agency approved cannabis-based medicine.
CBD and Epilepsy
The FDA has previously approved a synthetic cannabis medicine, but Epidiolex is different as it is manufactured from marijuana extract.
The FDA noted in its announcement that it informs and advises the DEA about scheduled substances such as marijuana. In April, an expert advisory panel for the FDA voted unanimously to recommend Epidiolex’s approval and determined that “CBD has a negligible abuse potential.” The potential for CBD to help with ailments with negligible abuse potential means that perhaps it could replace addicting pain medication like opioids.
GW Pharmaceuticals Epidiolex
Epidiolex was developed by a subsidiary of GW Pharmaceuticals which is a London based company. Skirting the harsh American restrictions on medicinal research for cannabis, this British company is now at the forefront of scientific treatment. It seems the laxer restrictions on medical cannabis research have put European countries at the forefront of research.
States’ rights will allow the ignoring of federal bills and allow patients to use health insurance to pay for the medication as early as September. This basically means that because states have ratified marijuana, the states’ rights override federal rights; this works much like issues of property taxes and speed limits for safety in a state. Legalizing marijuana isn’t enough protection in certain states; additional legislation has been added as doctors can recommend the plant extract, but dispensaries are not allowed to legally dispense it. In Colorado, The Colorado General Assembly passed HB 1187 in April to allow doctors to prescribe the drug upon the FDA’s approval; this creates protections similar to those for synthetic THC medication, like Marinol. This flies in the face of decades of political rhetoric, public policy and the legal standards underpinning cannabis prohibition.
The FDA approval was an essential step for Epidiolex, but being made from marijuana still defies the DEA’s rules; It will continue to be federally illegal to prescribe the drug until marijuana’s Schedule I status is changed or abolished.
CBD for Epilepsy
Colorado’s preemptive move will allow its’ doctors to prescribe the drug while other states with legal cannabis may have to wait. The passing of HB 1187 lifted previous prohibitions on pharmacists from being able to dispense marijuana-based medicine. However, similar restrictions in other states have to be taken by on a case-by-case basis. Hopefully, other states will look at Colorado as a template. It allows for not only prescription-strength CBD but full-spectrum hemp extracts as nutritional and wellness products. Similar to omega fatty acids, there exists prescription-strength and over-the-counter supplements.
Many hemp CBD businesses are based in Colorado thanks to the state’s relatively friendly laws for hemp farming and processing. CBD products are regulated through the Hemp Farming Bill.
GW said it expects that the DEA will reschedule CBD within 90 days.
In a statement, GW CEO Justin Gover said: Today’s approval of Epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies… These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.
The question remains: Will the government take this potentially transformational opportunity?
This is the first time the FDA has admitted that cannabis has medical value, specifically to treat serious epilepsy disorders. Approving Epidiolex directly refutes the legal basis for the absolute prohibition of cannabis in the United States.
Epidiolex is essentially a CBD tincture made for oral ingestion, and there are many counterparts available on the retail market today, like Green Lotus Hemp. The majority of CBD extractors use whole-plant infusion and CBD isolate techniques to make their products. Epidiolex is made by refining the marijuana concentrate down to a single molecule, which removes all THC before becoming the base for the medication.
Making Epidiolex legal does not legalize medical cannabis, nor does it authorize the medicine in the 30 states that have approved medical cannabis programs. In fact, it doesn’t even legalize CBD. The law continues to hold the vast majority of those substances illegal; the only exception being products developed from industrial hemp, as per the 2014 farm bill which Green Lotus Hemp products comply.
Epidiolex remains a Schedule I substance so other action is still required. To bring this product to market, the FDA, in conjunction with the Justice Department, must take another historic step: rescheduling a cannabis-based compound.
The decision to approve this drug effectively forces their hand on rescheduling. GW Pharmaceuticals’ assessment of the drug’s abuse potential, demonstrating it to be low, Epidiolex may be rescheduled from Schedule I to Schedule III or IV.
A combination of bureaucracy and politics has meant that researchers like GW pharmaceuticals abroad are beating U.S. researchers in studying this plant. Cannabis used in research is typically supplied by a single domestic source, namely a farm at the University of Mississippi. However, the DEA is becoming more open to expanding domestic producers. Despite dozens of applications from legitimate institutions, the Justice Department under Attorney General Jeff Sessions has refused to approve a single one.
FDA has signaled to the rest of the government, specifically the DEA, that cannabis-based medicines can have medicinal value and can be regulated for safe use in this country. Don’t let politics, but let medical and health professionals guide the department’s choices on federal cannabis policy. When federal regulators stand in the way of high-quality research, they are standing between patients and treatments that could improve or save lives.