Marijuana drug wins FDA approval-a first that may change federal regulations

FDA approves first cannabis-based drug

The U.S. Food and Drug Administration announced Monday that it's approved a marijuana-derived drug for the first time. He described it as the 'first and only FDA-approved cannabidiol medicine to treat two severe, childhood-onset epilepsies'.

Having an FDA-approved, pharmaceutical-grade CBD drug will open up a new treatment option for epilepsy patients by delivering a high-quality, consistent dose of CBD, says Robert Carson a pediatric neurologist at Vanderbilt University who treats patients with epilepsy.

The chemical used in Epidiolex, cannabidiol, is a component of the cannabis sativa plant, but does not carry the same psychoactive effects or "the high" that results from pure tetrahydrocannabinol (THC) consumption.

Dravet syndrome appears in early childhood causing frequent seizures, impaired motor skills, and hyperactivity. Unfortunately for both conditions it is estimated that 1 in 5 patients will die before reaching the age 20.

Given that CBD is an ingredient in marijuana, people often confuse it with taking "regular" marijuana.

Under the Controlled Substances Act (CSA), CBD is now a Schedule I substance because it is a chemical component of the cannabis plant.

England dare to dream after record win
The second-half was largely an anti-climax, with Jordan Henderson and Raheem Sterling going close to making it seven. And they're well on their way to doing that at half-time against Panama .

In clinical trials, patients administered Epidiolex, on average, obtained a 40 percent reduction in seizure frequency. It was shown to be more effective at reducing seizures, when taken with other drugs, than a placebo during these studies. The FDA noted in its announcement today that it informs and advises the DEA about scheduled substances.

According to the FDA press release, the most common Epidiolex-related side-effects were sleepiness, sedation, lethargy, elevated liver enzymes, appetite changes, diarrhea, rash, fatigue, malaise, weakness, insomnia, sleep disorder, poor-quality sleep, and infections.

Epidiolex will be marketed in the United States by GW's USA subsidiary, Greenwich Biosciences.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV. "It's an awesome plant with so many different chemical compounds that can fix medical problems", Defran said. "And, the FDA is committed to this kind of careful scientific research and drug development", said FDA Commissioner Scott Gottlieb. However, Schultz says his company plans to create more CBD medications. Interestingly, the warning focused not on the products' CBD content as violative of the CSA, but instead on the unproven and potentially fraudulent nature of the product's marketing representations.

The other epilepsy drugs in the market lead to serious risks like suicidal thoughts and attempts.

50 children in the United Kingdom have been given Epidiolex as a treatment as part of a large scale clinical trial that took in 1,500 kids worldwide. And now, after the FDA conducted its own trials using Epidiolex, the drug was finally given the approval.

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