FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe form of epilepsy
1. On June 25th, 2018, the U.S. Food and Drug Administration (FDA) approved the first medical use of Cannabidiol (CBD).
2. The approved drug goes by the name Epidiolex and is approved for the treatment of, quote – two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older – unquote.
3. This is the only approved prescription treatment for Dravet syndrome and the first FDA approved compound derived from marijuana.
4. Although present in marijuana, and often in higher concentrations in hemp, CBD is non- psychoactive.
5. According to the FDA Commissioner, Scott Gottlieb, the FDA is committed to supporting and evaluating therapies derived from marijuana that have been well studied and have been proven safe and effective. The FDA is also prepared to, quote – take action when they see the illegal marketing of CBD-containing products with serious, unproven medical claims – unquote.
6. Dravet syndrome is characterized by frequent fever related seizures early in life followed by involuntary muscle spasms as the child ages. The condition can be life threatening and is typically associated with, quote – poor development of language and motor skills, hyperactivity and difficulty relating to others – unquote.
7. Lennox-Gastaut syndrome has many of the same symptoms as Dravet syndrome but is not usually diagnosed until age 3 – 5.
8. Epidiolex’s was shown to reduce the frequency of seizures compared to a placebo for patients suffering from Dravet syndrome and Lennox-Gastaut. Evidence was collected from 516 patients involved with, quote – three randomized, double-blind, placebo-controlled clinical trials – unquote.
9. Even with its FDA approval, CBD remains a Schedule 1 substance in the eyes of the Controlled Substances Act due to its relation to the cannabis plant. As such, the developers of Epidiolex performed studies to determine its potential for abuse.
10. Due to Epidiolex’s potential to treat two rare syndromes with few alternative therapies, the FDA assigned Priority Review status, Fast-Track designation regarding Dravet syndrome, and Orphan Drug status as it related to both syndromes to its new drug application process. These designations served to speed Epidiolex’s official review, but in now way reduced the rigor of its testing or safety requirements.
11. As an agency of the U.S. Department of Health and Human Services, one of the FDA’s primary mandates is, quote – assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices – unquote. The source of this review is a press release produced by the FDA.
Source: FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe form of epilepsy. US Department of Health and Human Services. June 2018.
Review by: SP
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