FDA to Approve Cannabis-Based Seizure Medicine
Posted by Marijuana Doctors on 02/22/2018 in Medical Marijuana
Updated on February 2, 2019.
Medical content reviewed by Dr. Joseph Rosado, MD, M.B.A, Chief Medical Officer
The U.S. Food and Drug Administration has only a few months left to give the green light to a cannabis-based seizure medicine that epileptic patients across the country will be able to access. If approved, these patients will be able to pick up the medication from their pharmacy, just like any other prescription.
GW, a British pharmaceutical company, created the seizure-treating medicine called Epidiolex. The drug is more than 98 percent cannabidiol (CBD) and contains no tetrahydrocannabinol (THC), the psychoactive cannabinoid in marijuana. So, this is a medication that could even be used to treat children with epilepsy.
Who Is GW Pharmaceuticals?
GW Pharmaceuticals is leading the way in the development of marijuana-based medication. Through extensive drug discovery and development process, GW is able to use the most medicinally beneficial properties of cannabis to create medications that can treat specific illnesses.
The company is credited with creating Sativex, the first-ever prescription medication derived from marijuana plants. Sativex, used to treat spasticity from multiple sclerosis, is approved in 30 countries, not including the United States. However, it’s also on the FDA’s radar and is currently awaiting approval. It could also be effective in treating pain from cancer symptoms and treatment side effects.
Unlike Epidiolex, which is almost completely CBD, Sativex contains an equal 1:1 ratio of THC and CBD, as well as a range of other cannabinoids found in the cannabis plant. This is a significant reason Epidiolex has a better shot at becoming the first FDA-approved seizure medicine. These organizations are typically more wary of approving medications with prevalent THC contents that cause mind-altering effects.
How Epidiolex Helps Seizure Patients
How can Epidiolex help seizure patients? GW conducted a series of clinical trials to answer this exact question. One study included 171 patients between the ages of two and 55 who were diagnosed with Lennox-Gastaut syndrome, a severe form of epilepsy. Subjects were randomly and blindly assigned either Epidiolex or a placebo, which they took over a designated period.
Before participating in the study, the group had attempted taking six different seizure medications to no avail. They also were experiencing an average of 74 “drop” seizures in a month, which involves the entire body and can lead to falls or additional injuries.
After a 14-week treatment period, 22 percent of the patients in the placebo group saw a reduction in the frequency of their seizures, compared to 44 percent of the patients taking Epidiolex. More patients who received the drug also reported experiencing at least a 50 percent reduction in drop seizures.
How CBD Helps Seizure Patients
Since Epidiolex is almost entirely made of CBD, it’s no surprise the medication is effective in treating seizures due to epilepsy. We’ve known about CBD’s ability to treat these conditions and symptoms for many years.
CBD is one of more than 400 cannabinoids that make up the marijuana plant. These compounds bind to receptors in our bodies’ endocannabinoid system (ECS), a bodily network responsible for controlling a variety of functions, such as your mood, immune responses, movement, sleep habits, appetite and cognition, to name a few.
Along with THC, CBD is one of the most prominent cannabinoids in the plant. However, unlike THC, CBD has no psychoactive qualities, so it does not make the user feel “high.” The substance, like cannabis in general, has fewer, less severe side effects than most other epilepsy medications.
Of course, everyone reacts differently to medical treatments. Even if patients benefit from Epidiolex, the drug could also cause vomiting, diarrhea and other side effects. Most would agree, though, that these symptoms are worth the significant decrease in seizures patients experience.
How Soon Can We Expect FDA-Approved Cannabis-Based Drugs?
Despite its medicinal benefits and lack of psychoactive effects, CBD products derived from a marijuana plant are still seen as illegal in the eyes of the federal government. If the FDA approves Epidiolex, it will be the first plant-derived medication patients will be able to use nationwide.
The agency does not have to approve Epidiolex, and they have until June 27, 2018, to make their decision. If the FDA genuinely bases its choice off data from clinical trials, there’s a decent chance Epidiolex could be approved. Most insurance companies would likely cover the medicine, too, which is great — The New York Times reported Epidiolex could otherwise cost patients between $30,000 and $60,000 a year.
The Future of Cannabis-Based Drugs
If the FDA approves Epidiolex, it would be a monumental achievement for the medical cannabis industry. Perhaps it will take an independent government agency like the FDA acknowledging marijuana’s benefits to convince our federal authorities to take another look at the nation’s cannabis laws.
While epilepsy is an incredibly prevalent condition that cannabis has been proven to treat time and time again, it’s just the beginning of the list. There are so many medical conditions and symptoms medical marijuana can help patients manage, control or treat. If this trend conditions, Epidiolex is just the first of many drugs the FDA will approve in the future.
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