FDA Approves Cannabis-Based Epidiolex for Kid Seizures

Epidiolex — The FDA Approved CBD Solution For Kid Seizures

The U.S. Food and Drug Administration (FDA) this summer approved a cannabis-based drug, Epidiolex, to treat rare childhood seizure disorders, a historic move for the agency. We previously wrote about Epidiolex when GW Pharma was in development of the groundbreaking treatment plan [Read more here].

The active ingredient in Epidiolex is cannabidiol (CBD), the most potent non-psychoactive (i.e. won’t get you high) component in marijuana. The FDA, as of June 2018, approved Epidiolex to treat Dravet syndrome and Lennox-Gastaut syndrome. These are rare, heartbreakingly severe types of epilepsy disorders that cause seizures in babies and toddlers.

“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. And, the FDA is committed to this kind of careful scientific research and drug development,” FDA Commissioner Scott Gottlieb said in a press release. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products.”

Both seizure conditions are resistant to treatment with common epilepsy drug combinations, treatment regimens which many times come with debilitating side effects. Studies proved Epidiolex side effects are mild compared to those of standard medications.

This is the first time U.S. federal authorities have approved a CBD-based drug for medical use. The only other marijuana derivative FDA-approved for use in the U.S. is dronabinol (sold under the brand name Marinol), a synthetic form of Delta-9 tetrahydrocannabinol (THC).

CBD oil is extracted from the raw cannabis plant into an oil that, in Epidiolex, is 98% CBD.

Isolated in the mid 20th century, THC is the main psychoactive cannabinoid in marijuana. Dronabinol (Marinol) has been in use for decades as an anti-nausea and appetite-stimulating drug for cancer and AIDS patients.

Federal officials categorize Dravet and Lennox-Gastaut syndromes as “orphan” diseases, meaning there are few drug companies researching treatments because of slim profit potential. This designation allowed GW to fast-track its double-blind, placebo-controlled clinical trials of Epidiolex, which proved successful.

Read our scientific review of epilepsy and cannabis treatments.

This approval opens the door for further research into CBD-based drugs to treat a host of disorders. Scientists have found tantalizing preliminary evidence that CBD could treat disorders as varied as insomnia, anxiety, post-traumatic stress disorder, schizophrenia and others.

That Epidiolex is now available throughout the country by prescription opens up the potential for doctors to prescribe it for off-label uses, providing relief for patients with stubborn conditions other than seizure disorders. This is standard practice with many other prescription drugs. Starting dosage is set at 2.5mg/kg taken twice daily, orally. Detailed dosage information for Epidiolex is listed below, from the FDA filing:

GW Pharmaceuticals, the British maker of marijuana distillate Sativex, is the manufacturer of the new CBD drug. Sativex is not available in the U.S., but it’s prescribed in Europe for a number of conditions.

For more information on Sativex, see our “Spotlight on Sativex” article.

What Is Dravet Syndrome?

Dravet syndrome is a seizure disorder that begins in an infant’s first year and lasts the rest of their lives. The child’s development is normal until the onset of seizures, and because of this, it’s often misdiagnosed. Kids with Dravet usually have developmental problems resulting from the syndrome.

The long trail towards the approval of Epidiolex almost certainly started with the case of Charlotte Figi— a young girl whose Dravet Syndrome was treatment resistant until her parents worked with cannabis breeders to develop a high-CBD strain now named Charlotte’s Web.

A young Charlotte Figi, the brave little girl who first brought awareness to CBD being useful for seizures, sits in a garden of cannabis plants.

What Is Lennox-Gastaut Syndrome?

Lennox-Gastaut syndrome is a particularly nasty form of childhood epilepsy. It’s marked by frequent violent seizures which can lead to injuries, and which can’t be controlled by existing medication. The syndrome also comes with a host of developmental problems, including psychiatric disorders, cognitive deficits and behavioral problems.

For more information on Epidiolex, the syndromes it treats, and GW Pharmaceuticals, see our 2017 “Spotlight on Epidiolex” article published during the drug’s clinical trials.