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FDA Approves first Cannabis Medication: Epidiolex

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The good news just keeps coming in the intriguing world of CBD, and we are not at all complaining.

During the week of June 23, 2018, the Food and Drug Administration (FDA) approved a cannabis-based drug for the first time in history, giving the green light to patients suffering from epilepsy to use an oral CBD solution called Epidiolex, for the treatment of two rare forms of epilepsy – Lennox-Gastaut syndrome and Dravet syndrome – in patients aged 2 and older.

Epidiolex is the first drug to have achieved the high standards and rigorous criteria the FDA needed to see evidenced before approving any cannabis-derived drug for medical therapy, giving the parents of children with these very unfortunate and debilitating conditions, a new hopeful and positive outlook for their kids’ futures.

CBD, or cannabidiol, is the non-psychoactive healing agent found in the cannabis plant helping common conditions like pain and anxiety, inflammation, focus and improvement in mood, as well as more severe conditions like epilepsy.

Here, we give you the scoop on the first ever CBD medication approved by the FDA.

What Epidiolex is Treating

The two conditions this new drug will treat – Lennox-Gastaut syndrome and Dravet syndrome – are both rare and severe types of childhood-onset epilepsy.

To provide a better understanding of the conditions, Lennox-Gastaut syndrome usually starts in children between the ages of 3 and 5. It is characterized by frequent seizures, many of which are tonic, meaning there is a sudden stiffening of the muscles in the limbs and other parts of the child’s body.

Almost all of the children diagnosed with this condition also develop intellectual disabilities, with most of them furthermore requiring assistance with basic daily activities like eating and playing.

The other type of childhood-onset epilepsy, Dravet syndrome, appears in the first year of infancy, beginning with febrile seizures, when an infant or child’s body temperature rises due to infection or inflammation of some sort, causing a seizure or convulsion.

In addition to febrile seizures, other types of seizures are experienced as Dravet syndrome advances. Some children also develop something called “status epilepticus,” where they experience continuous seizures that require emergency intervention. If this happens, patients with this syndrome develop poor language ability, impaired motor skills, hyperactivity and may find it difficult to relate to others as they get older.

All in all, these difficult-to-control seizures that babies and children experience have a profound impact on their quality of life, making it challenging for both the child and parent to live a normal life.

Thanks to CBD-based Epidiolex, these seizures should be significantly reduced and therefore, enhance the quality of life for the children affected.

How this CBD Medication is Helping

FDA Commissioner Dr. Scott Gottlieb reported in an official statement that: “It was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition,” referring to the decision to approve Epidiolex.

According to Dr. Gottlieb, Epidiolex will provide a significant and needed improvement in the therapeutic approach to caring for people with Lennox-Gastaut and Dravet syndrome patients.

The CBD-based medication was tested in three randomized, double-blind, placebo-controlled trials, revealing the drug is indeed effective in reducing the frequency of seizures in children with these two types of syndromes.

Dr. Gottlieb stated the approval of the medicine demonstrates the FDA’s commitment to ensuring any new therapies from marijuana and its constituents are “safe, effective and manufactured to a high and consistent quality.”


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