On Monday, June 25th, in a 13-0 unanimous vote the Food and Drug Administration (FDA) approved the country’s first ever drug derived from marijuana. This drug is called ” Epidiolex ” and is intended to treat two different forms of epilepsy called Dravet and Lennox-Gastaut syndromes. It is important to note that “Epidiolex” does not contain THC. Instead, it contains CBD which is a different cannabidiol. As the FDA itself notes, “this is the first FDA-approved drug that contains a purified drug substance derived from marijuana.”
This new FDA acknowledgment of the medicinal value of CBD should come as good news to marijuana startups that have been eyeing the compound for consumer and more importantly medical use. Cannabis-derived CBD products are currently available where recreational marijuana is sold. There is a CBD derived from industrial hemp that faces fewer regulations and is even stocked by some grocery stores. By some measures, consumer interest appears to be moving away from traditional high-potency THC-based products and more toward CBD instead. CBD is one of the non-psychoactive cannabinoids that has many different health properties, making it the perfect base for medication. CBD’s use in seizure prevention is well documented in reputable research, and now, after conducting its own trials, the FDA is finally ready to allow it for medical use. CBD’s benefits include, but are not limited to, pain relief from its anti-inflammatory properties, anti-anxiety, aids digestion, sleep, and the list goes on. There is evidence prior to the “Epidiolex” study that suggests CBD could be useful not just for epilepsy, but a broad spectrum of neurological diseases like Parkinson’s, Alzheimer’s, multiple sclerosis, and some brain cancers.
“Epidiolex” will be given to patients in the form of oil injected through the mouth. By ingesting oils instead of candied edibles, the patient will find relief in about 20-30 minutes instead of approximately over an hour as the cannabis oil does not digest the same as food. Thus, the oil will relieve epileptic side effects much faster this way. In the clinical trials, “Epidiolex” was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.
So, what is Dravet and Lennox-Gastaut syndrome? They are very severe epileptic conditions that typically emerge in the first few years of life. Patients suffer from severe seizures, and an estimated 20 percent of patients die by the time they are 20 years old.
Lennox-Gastraut syndrome (LGS) is a type of epilepsy with multiple different types of seizures, particularly tonic (stiffening) and atonic (drop) seizures. In most cases intellectual development is impaired. LGS accounts for only 2% – 5% of childhood epilepsies. Children with this type of epilepsy will need a lifelong treatment plan. As of today, there is not cure for this type of epilepsy, only relief from medication.
Dravet syndrome is a rare genetic epilepsy that begins in the first year of life in an otherwise healthy infant and will need to be treated for the remainder of the child’s life. Symptoms include many different classifications of “jerking” style spasms in the muscles. Most children will develop mild developmental disabilities dues to the syndrome. It is reported that about 8 out of 10 people with this syndrome have a gene mutation that causes problems in the way that ion channels in the brain work. This mutation is most often not inherited from the parents but is considered a new mutation in the child.
In trials, patients taking “Epidiolex” saw their monthly seizures reduced by about 40 percent. There are very little known possible side effects of “Epidiolex”, especially when being compared to anything else Big Pharma has to offer for epilepsy. Some patients experienced sleepiness or gastrointestinal issues in the trials. There is also a small concern about the effect of the drug on the liver. Doctors are aware of this possible side effect and will be monitoring liver function closely during treatment. Like any new drug, we won’t know whether it lives up to what it claims to do for a while. What’s clear now is that this new medication will permanently change the way we talk about cannabis in the United States. Currently, cannabis is as legal as alcohol in Washington, DC and eight states, including the entire West Coast. But doctors, scientists, and hospital administrators are governed by federal, not state law, which makes studying cannabis a risky, time-consuming endeavor. That’s about to permanently change.
Stores such as Riteaid have already agree to sell ‘Epidiolex’ once the DEA reschedules it. “Rite Aid pharmacists fill prescriptions in accordance with all state regulations and laws as well as those set forth by the DEA and FDA,” said Rite Aid spokeswoman Ashley Flower. “Given that ‘Epidiolex’ has received approval from the FDA, upon being rescheduled, Rite Aid expects to fill prescriptions for ‘Epidiolex’ later this year based on availability.”
The Drug Enforcement Administration continues to classify marijuana as a Schedule I drug. This means that it has no proven medical value and a high risk of abuse. If “Epidiolex” is approved, the DEA will then have to reschedule cannabidiol — given that FDA approval demonstrates a medical value — but can leave cannabis overall at Schedule 1. The FDA has already previously approved synthetic medications that resemble or are identical to THC. The drugs, which are approved to treat nausea from chemotherapy and other conditions, are listed at Schedule III and Schedule II, respectively. Thus, there is great hope that CBD will be rescheduled soon, possibly as soon as the end of this year.
Currently there are about 50,000 patients affected by Dravet and Lennox-Gastaut syndrome. However, there is already evidence that Epidiolex could help with dozens of different types of seizures and epilepsy syndromes. The FDA Commissioner Scott Gottlieb gave a statement, “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.” This being said; the future seems bright for the use of cannabis as medicine.
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FDA Approves the First Cannabis Medication – By: Helena Starks