Epidiolex will only be available for patients suffering with the two forms of epilepsy, but this is still considered to be a considerable step forward for medical marijuana research.
Shaun Hussain, MD, a pediatric neurologist at Ronald Reagan UCLA Medical Center in Santa Monica, says that while the FDA's approval of a marijuana-based drug is "indeed a big deal", it is also significant because "it offers another drug for Lennox-Gastaut and the first-ever drug for Dravet". The medication does not contain THC, the primary psychoactive component in marijuana that causes the "high" associated with its use. Dravet syndrome is estimated to effect about 1 in 40,000 people.
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Most patients with LGS and Dravet require several drugs and are resistant to many now approved epilepsy drugs.
Epidiolex is a cannabis-based product and is said to help reduce the number of seizures. As of last week, the company hadn't determined the price but was in preliminary talks with insurance companies to make them aware Epidiolex is coming, he said. However, Epidiolex does not contain THC, the component of marijuana that gets people high, Jamie Alan, an assistant professor of pharmacology and toxicology at Michigan State University, tells Yahoo Lifestyle. "And, the FDA is committed to this kind of careful scientific research and drug development", Scott Gottlieb, FDA's current commissioner, said in a statement.
During clinical trials, the researchers were able to observe the following effects: sleepiness, sedation, lethargy, fatigue, elevated liver enzymes, decreased appetite, diarrhea, rash, malaise, weakness, insomnia, poor quality sleep, and various infections.
"This is an important medical advance", Gottlieb said.
"These don't have to be huge trials, because Angelman syndrome is a rare disease", Bichell said, "but it would still be important to know definitively if this is the right drug for AS". FDA has determined that CBD has negligible abuse potential.
The article does not state exactly when the drug will be on the USA market, but generally, FDA approval coincides with market availability. Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. An EMA decision on whether to recommend approval is expected in the first quarter of 2019.