What is it to take the first marijuana drug from the FDA

The Food and Drug Administration (FDA) went into history Monday by approving Epidiolex, an oral drug that uses cannabidiol (CBD), a chemical compound found in marijuana, but that does not cause cancer. high risk, for the treatment of Lennox-Gastaut. Dravet syndrome, two rare forms of epilepsy. (In addition to being the first FDA-approved drug derived from marijuana, Epidiolex is also the first drug approved specifically for Dravet syndrome.) In three clinical trials involving more than 500 people, the drug has been shown to reduce the frequency of seizures associated with these conditions. Although the Drug Enforcement Administration needs to reclassify CBD as a non-Schedule I drug before the drug can enter the market, the manufacturer GW Pharmaceuticals says it will be available to patients at the same time. 39, autumn 2018.

This is the story of Maya Adache, a 10-year-old girl in South Florida with Dravet syndrome. Since taking Epidiolex, his fits and mood swings have almost completely disappeared, according to his father, Adam Adache.

Maya had her first attack when she was about six months old. She was feeding at that time with my wife, and we noticed her eyes roll on one side and she became limp. We thought she was falling asleep while eating, which babies sometimes do. It happened again, then a third time, and we started to be a little nervous. We called the pediatrician and he said that he could be acting out of a febrile seizure, a crisis caused by fever.

We brought her, and she was quite consistent and acted like a normal six-month-old. Then we went back home and it happened again, so the doctor said to take it to the emergency for observation. That night, she had a grand mal crisis – the complete convulsions that people think about when they think of seizures – for more than an hour. They could not control it. It was absolutely terrifying. In the end, she was in the hospital for four days. The same thing repeated four months later. She continued to have seizures, so they put her under her first treatment.

She was very late to be diagnosed with Dravet, nearly nine years old. About 80% of patients have a specific genetic mutation associated with Dravet, but not Maya. She has just been diagnosed with refractory epilepsy for a long time, which means the drugs will not work. Nothing worked. Some drugs worsened the situation – some worsened the situation – and some of them simply did not help.

She had 10 convulsions a day. She had lots of bindings, where she just stared and she was really not consistent. She had convulsions with convulsions. She had others where she would do something like snapping her lips, but she had no gratitude and would not remember anything when she would come. She also has a lot of developmental delays, language delays and language delays, which is very typical of people with Dravet syndrome. He also comes with behavioral problems. She had mood swings that were almost impossible to deal with, because they came without rhyme or reason.

When we heard about the clinical trial at Nicklaus Children's Hospital in 2016, we were in desperate mode, to be honest. We were doing what the desperate parents do: you go out there and read everything and, hopefully, make your own enlightened assumptions. We have heard about an essay of a drug derived from marijuana. I am not a big marijuana advocate and you do not want people to think that you are giving marijuana to your child. But we thought, finally, that there is something that is really regulated, a pharmaceutical grade drug that works really well. And there is not the THC that makes you go up, which obviously made us feel better from the beginning. Although we thought about the stigma associated with the name, we were really excited to try the product and we really thought it would help. We were ecstatic about being in the clinical trial.

It's really impossible to say for which child this will work, but for us it was great. I do not mean that his seizures have been eliminated, because we notice something from time to time, but sometimes we spend weeks without seeing a crisis, and we have not seen convulsions. She had trouble sleeping and early stomach pain, but the side effects were minimal. This is not a miracle drug, but it has changed the lives of our family for sure, simply because she is much happier. I will not say it once and even if it does not merge, but my other child also has a seizure once in a while!

Assuming it works well, it will greatly benefit Maya and her quality of life. Already, it's changed. We put her in camp and she stayed there all day; it would never have happened before. Maya was skating when she was a child, and she was struggling a lot, but it was something she hung on. Now she has improved even more. Most recently, she won a gold medal at a Special Olympics regional competition. She can skate for an hour or two or three. She takes breaks, but she can do it. She loves him.