FDA Approves First Medical Marijuana Product
- Aug 06, 2018
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Epidiolex, the first cannabis-derived drug, has been approved by the FDA for medical use. This drug reduces seizures in certain types of pediatric epilepsy.
What is it?
Epidiolex was created by a British manufacturer called GW Pharmaceuticals. The company studied the drug in over 500 children and adults suffering from seizures that are difficult to treat.
It is basically a pharmaceutical-level version of CBD oil. Many parents who have children with epilepsy have already been treating their condition with CBD. There are more than 80 active cannabinoid chemicals found in cannabidiol, but unlike THC, it does not produce a feeling of being high.
Epidiolex is the “first pharmaceutical formulation of highly-purified, plant-based cannabidiol (CBD), a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs.”
Epidiolex will be available to patients throughout the US, not just where marijuana is already legal for medicinal purposes.
This oral solution is a strawberry-flavored syrup that is to be taken twice daily and has been approved for patients 2 year of age or older. It is set to be available in the fall of 2018.
According to the Epilepsy Foundation, up to one third of Americans with epilepsy have not found a therapy that will control their seizures.
A rare type of pediatric epilepsy, Lennox-Gastaut syndrome typically begins within years 3 and 5.
Many of the seizures Lennox-Gastaut syndrome sufferers experience are tonic, which means the muscles in the limbs stiffen suddenly.
Most children with this form of epilepsy also develop intellectual disabilities, and many of them additionally require assistance with basic everyday activities.
Another rare type of pediatric epilepsy, Dravet syndrome begins within the first year of life, beginning with febrile seizures. More types of seizures are experienced as the condition advances.
Some children experience a state called “status epilepticus,” where they suffer from continuous seizures that require emergency action.
During clinical trials, those suffering from Dravet syndrome who took this drug experienced 39% less seizures, and those with Lennox-Gastaut syndrome saw a decrease of 37%.
Possible Side Effects
The main side effect that came from the trial was liver toxicity, which appeared as increased liver enzymes.
The most common noted side effects were lethargy, fatigue, a decrease in appetite, increased liver enzymes, diarrhea, rashes, weakness, insomnia, poor sleep, and infections.