First Drug Made From Cannabis Approved by the FDA For Dravet Syndrome and Lennox-Gastaut Syndrome

According to a story from the Washington Post, the US Food and Drug Administration (FDA) has cleared the approval of Epidiolex®, a solution whose active ingredient is a refined version of cannabidiol (CBD), a substance derived from cannabis. The drug contains only trace amounts of THC, and therefore has no psychoactive effects.

What is Epidiolex®?

Epidiolex is an anti-seizure medication and has been approved to treat two forms of rare, severe childhood epilepsy: Dravet syndrome and Lennox-Gastaut syndrome.

Dravet Syndrome Explained

Dravet syndrome begins to first display symptoms at just six months of age, and can cause frequent seizures that are commonly triggered by warm temperatures and fever. The syndrome is caused by a genetic mutation, but it is rarely inherited and tends to appear as a new mutation in most patients. Seizures tend to get worse as patients age, and other symptoms include problems with movement, cognitive impairments, sleep issues, and behavioral disorders.

Lennox-Gastaut Syndrome Explained

Lennox-Gastaut syndrome normally appears between two and six years of age. Patients with this syndrome can experience a diverse range of seizure types, often occurring many times per day. Many patients also have delayed development, behavioral abnormalities, and intellectual impairments that can range from moderate to severe. The cause of the syndrome is not always known, but it can be triggered by other diseases and brain injuries. A significant portion of Lennox-Gastaut cases are derived from West syndrome.

Epidiolex’s FDA Approval

Epidiolex was approved for use by patients aged two years or older that have either Dravet syndrome or Lennox-Gastaut syndrome. The frequent seizures, which normally occurr many times per day without treatment, put patients at significant risk of injury. Many patients wear helmets for much of their lives to avoid injury. While scientists expect the new drug to get approved for other types of epilepsy as well, Epidiolex also represents the first treatment approved by the FDA specifically for Dravet syndrome.

The Role of Cannabis in Epidiolex

Scott Gottlieb, the FDA commissioner, emphasizes that the approval is not meant to symbolize a broader endorsement of cannabis as a whole for medical use. The agency has previously approved some medications with synthetic versions of substances found in cannabis, but this is the first drug that is directly derived from cannabis plants.

Nevertheless, the approval is a major milestone for medical marijuana advocates. Justin Gover, the CEO of GW Pharmaceuticals which was responsible for developing the medication, had this to say:

“We are just scratching the surface of what could be a range of cannabis-based medications.”

Cannabis and all its active ingredients are still listed by the Drug Enforcement Agency (DEA) as Schedule I substances that allegedly have questionable safety, a high potential for addiction/abuse, and no medical value. The DEA is expected to reschedule CBD in the next 90 days.

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