According to a press release, the U.S. Food and Drug Administration (FDA) approved GW Pharma's drug Epidiolex for the treatment of rare forms of epilepsy. It is used to treat two rare forms of epilepsy in patients 2 years of age and older.
"Today's approval of epidiolex is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies", said Justin Gover, GW's Chief Executive Officer.
Epidiolex would also be the first approved therapy for DS, treatments for which are now limited to a combination of seizure medication and drugs to prevent emergencies.
Dravet syndrome appears in early childhood causing frequent seizures, impaired motor skills, and hyperactivity.
FDA commissioner, Scott Gottlieb, welcomed the news as an "important medical advance", and said that Epidiolex "provides new options for patients".
Epidiolex will be supplied as a 100mg/mL strawberry-flavored oral solution in 100mL bottles and is expected to be available for appropriate patients in Fall 2018. There are six other drugs approved to treat seizures associated with Lennox-Gastaut, but none approved for Dravet. Carriker said when combined with other medications, her daughter's seizures reduced by about 50 percent. 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.
While the drug is made using the CBD, which is a component in Cannabis, it is nonpsychoactive, meaning it doesn't make you high.
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As a result, Epidiolex's launch remains at the discretion of the DEA, which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, so as to allow GW to begin selling it.
The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.
"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters.
FDA's Gottlieb warned about the use of CBD products with "unproven medical claims".
Now that FDA approval has been granted, the producers of the drug now expect for it to be available by the autumn.
The other epilepsy drugs in the market lead to serious risks like suicidal thoughts and attempts.