FDA Approves Epidiolex, the First Cannabis-based Drug

In what will probably be counted as one of most historic, game-changing breakthroughs in the journey to validity and universal acceptance of medicinal cannabis and the associate industry, the U.S. Food and Drug Administration (FDA) approved a drug that is cannabis-based and will be widely available to help treat symptoms associated with Epilepsy.

Epidiolex, made by GW Pharmaceuticals PLC, a biopharmaceutical company based in the UK, is an oral solution that’s administered twice a day to help treat two severe epileptic syndromes that can strike children 2 years of age and older. One of these is called Dravet syndrome, which is a genetic brain disorder that causes a variety of epileptic seizures, problems with language and speech, issues with behavior and physical stability, and mobility. The disorder can begin as early as a child’s first year of life. The other syndrome is called Lennox-Gastaut syndrome, and it can affect children between the ages of 3 and 5, producing numerous types of seizures.

The introduction of this significant advance in medicinal cannabis is partly attributed to the thorough and closely monitored clinical studies that helped to secure the approval of Epidiolex. Now that the drug has passed the major hurdles to become a prescribed medicine, doctors and medical professionals have greater assurance that the drug is consistent on all levels and will perform as prescribed.

Epidiolex is the first drug of its kind that is a formulation of highly-purified, plant-based cannabidiol (or CBD), which doesn’t carry the high associated with marijuana. Cannabidiol is one of the active cannabinoid chemicals in marijuana, which number over 80.

Not only was Epidiolex created to treat Dravet and Lennox-Gastaut syndromes, but also tuberous sclerosis complex and infantile spasms which originate while a child is still an infant, and cause the body and limbs to stiffen suddenly and the head to bend forward.

Over 1 million families—or over one-third of Americans who have epilepsy have had no therapies to help them control their symptoms. Now, at long last for their benefit and improved quality of life is Epidiolex. In two experimental clinical trials that targeted the two syndromes with the most severe symptoms of seizures—Dravet syndrome and Lennox-Gastaut syndrome, patients who took Epidiolex experienced “great reductions” in some specific types of seizures versus those who took a placebo. In fact, one of the first patients to try Epidiolex gave a powerful testimony to the seizure-reducing and life-changing effect the drug had on his life after taking it.

The many studies that took place during the period leading up to the approval of Epidiolex involved human trials using double-blind, random, control groups on placebos. These kinds of trial studies are the most prestigious of all types of studies, and are the ones that are prized for a new medicine to be considered worthy for widespread use. There has been over 3,800 years of use of cannabis in the treatment of epilepsy to varying degrees of effectiveness, but now there is solid proof that CBD cannabis works.   

With existing medical treatments for epilepsy unable to treat the symptoms for the young patients that have rare epilepsy syndromes like Dravet or severely debilitating syndromes like Lennox-Gastaut with its multiple types of seizures, the benefits from studies conducted with Epidiolex resulted in some of the children studied becoming entirely free of seizures during the study period of 14 weeks, and overall, many parents from the group using the cannabidiol saying that positive changes were noticed in their children that the children that were in the group taking the placebo.

The approval of the first cannabis-based drug means that patients suffering from the severest forms of epilepsy will have access to a cannabinoid-based treatment very soon that’s prescribed by a doctor and accessible under insurance coverage, and can be monitored under the care of a physician.

Epidiolex has met FDA standards, which will make it available to thousands of patients that can benefit from its seizure-controlling capabilities. More importantly, Epidiolex’ approval opens the door for closer studies involving cannabis to uncover more health-related uses and treatments for medicinal cannabis. This is just the beginning!

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