It's not only the first cannabis-derived medicine to be approved by the FDA, but also the first approval for a drug created to treat Dravet Syndrome, a condition accompanied by hyperactivity, impulsiveness, autistic type behaviours and other developmental disorders as well as seizures. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome. It is a chemical component of the Cannabis sativa plant and does not cause the intoxication or euphoria that comes from tetrahydrocannabinol (THC).
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".
Before sales of Epidiolex can begin, the DEA must formally reclassify CBD into a different category of drugs that have federal medical approval.
Dravet syndrome is a rare genetic condition that usually shows up in infants, starting with fever-related seizures and progressing to other, more severe seizure types. "These patient populations desperately need new treatment options to help control their seizures and the results of the clinical trial in both disorders are very promising". GW's subsidiary Greenwich Biosciences will market the drug in the US.
As part of Epidiolex's approval process, it must be rescheduled by the US Drug Enforcement Agency (DEA) from its current standing as a Schedule 1 drug, meaning it has no recognised medical use and a high potential for abuse.
The first-ever medical treatment derived from a marijuana plant will hit the USA market in a few months after regulators yesterday gave the epilepsy treatment the green light. "This should allow patients to have access to consistent cannabidiol doses made to the highest quality standards". "We'll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims".
The drug set to be launched in autumn in the United States market is for treating rare and severe forms of epilepsy - Lennox-Gastaut syndrome (LGS) and Dravet syndrome in patients aged 2 and older. "It's being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits", Gottlieb said. Common side effects include sleepiness, elevated liver enzymes, decreased appetite, diarrhea, rash, and weakness.
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