Marijuana-Based Drug Nears Approval for Childhood Epilepsy

On September 26, a marijuana-based childhood epilepsy drug took a step closer to winning approval when its maker announced promising phase 3 clinical trial results. [1]

Justin Gover, CEO of the British biotech company GW Pharmaceuticals, said that the children participating in the trial had previously tried 10 other anti-epileptic drugs. Despite using the medication, the young participants still experienced 3 seizures a day, approximately 90 a month. Said Gover:

“The impact that we have had that we have shown today is a hugely important potential breakthrough in the treatment of the condition called Lennox-Gastaut syndrome.”

Epidiolex is a drug made with pharmaceutical cannabidiol (CBD). The drug helps treat Lennox-Gastaut syndrome, as well as Dravet syndrome. Cannabidiol oil has been shown in past studies to reduce – and halt – other forms of epileptic seizures. [2]

Read: Marijuana Compound Shows Promise in Helping Kids with Dravet Syndrome

CBD does not cause the “high” associated with THC, the psychoactive substance in marijuana, but shows great promise in treating central nervous system disorders, according to Gover. He believes the drug could also be useful in treating a range of other conditions, including schizophrenia and behavioral disorders.

Epidiolex does have some side effects, however. Some of the children experienced drowsiness, decreased appetite, diarrhea, and vomiting.

The phase 3 clinical trial results revealed that patients taking 20 mg of Epidiolex had a 42% reduction in seizures versus a 17% reduction for those on placebo.

Gover boasted:

“The good news is this is actually the third positive trial within the field of treatment resistant childhood onset epilepsy that we have reported results for in the last six months.” [1]

GW Pharmaceuticals said it plans to file a new drug application with the U.S. Food and Drug Administration (FDA) in the first half of next year.

The company, which grows its own cannabis plants to study the ingredients and then synthesizes it into medication, already has 1 product on the market called Sativex – a mouth spray to treat muscle spasms associated with multiple sclerosis (MS).

No FDA-approved treatments for Dravet syndrome currently exists. Patients with the condition frequently experience prolonged and severe seizures early in life, as well as developmental delays.

Gover said:

“There’s remarkable consistency in the data here with what we’ve seen in the previous trial results. That will help us make our case to the FDA.” [2]

Sources:

[1] CNBC

[2] Fortune

University of Alabama at Birmingham