On June 25, the U.S. Food and Drug Administration (FDA) approved GW Pharmaceuticals Plc’s epilepsy treatment, making it the first cannabis-based drug to win national approval and opening the floodgates for more research into the medicinal benefits of cannabis.
Epidiolex (Cannabidiol) is an oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. In clinical trials, the treatment was shown to reduce the number of seizures by approximately 40 percent in patients with the two types of epilepsy.
Cannabidiol—or CBD—is a chemical component of the sativa plant of marijuana. CBD is not the primary psychoactive component of cannabis, which means THC is responsible for producing the “high.”
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies,” FDA Commissioner Scott Gottlieb said in a statement. “And, the FDA is committed to this kind of careful scientific research and drug development.”
As expected, FDA officials had pointed out they supported approving Epidiolex. Although there was some concern with regard to the drug’s effect on the liver, experts have stated this risk could be addressed by doctors as they monitor their patients during treatment. Other side effects include sleepiness, lethargy, fatigue, insomnia, rash, malaise, and infections.
Before GW can introduce Epidiolex into the market, however, the Drug Enforcement Administration must reclassify CBD since it is derived from cannabis, which is known as a Schedule I narcotic. The agency is expected to make a decision within 90 days.
Lennox-Gastaut syndrome starts in childhood, usually between three and five years of age. It is characterized by multiple types of seizures. Over three-quarters of those with the health condition have tonic seizures, which cause the muscles to contract uncontrollably.
Dravet syndrome is a rare genetic condition which is apparent during the first year of life with febrile seizures (frequent fever-related seizures). Down the road, other types of seizures often arise, such as myoclonic seizures and status epilepticus.
Children with any one of the conditions typically experience poor development of language and motor skills, requiring help with day-to-day activities.
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