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GW Pharmaceuticals, a London-based medical cannabis research and technology firm, released new data about its latest clinical trial for Epidiolex, the company’s flagship, pharmaceutical-grade CBD oil product.

During the study, researchers focused on a devastating form of epilepsy called Lennox-Gastaut Syndrome. The results showed that Epidiolex is effective in reducing the occurrence of seizures in patients who participated in the trial.

“It’s fabulous,” said Justin Gover, chief executive of UK-listed GW Pharmaceuticals. “March was a breakthrough moment, but these results take us to a different place and to have a second study to be so robustly positive and consistent with the first, shows that it was no fluke.”

Clinical Trial Results

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The phase three study included both children and adults suffering from the disease. Prior to the trial, all of the participants were having an average of 74 hard-hitting seizures every month. Scientists created two groups from the sample pool: 86 patients were given CBD treatment in addition to their daily medications, while 85 participants were given a placebo. Individuals who were taking Epidiolex reported a 44 percent decrease in seizures (the placebo group reported a 22 percent decrease).

The late-stage clinical trial also uncovered several side effects that were previously unaccounted for in the initial study. A total of 74 patients who were taking Epidiolex experienced mild side effects, which includes any or a combination of the following symptoms: sleepiness, diarrhea, vomiting and loss of appetite. Strangely, 59 participants in the placebo group also experienced similar side effects. Only 12 individuals from the group receiving CBD oil dropped out from the study, because of the secondary symptoms (one person taking the placebo form of the drug exited the trial prematurely).

Regulatory Hurdles

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GW Pharma may encounter issues during the application filing process for the release of Epidiolex. Its previous offering, Sativex, the world’s first prescription cannabis medicine that helps reduce symptoms associated with spasticity from multiple sclerosis, underwent a rigorous country-by-country approval process in the EU. The firm is prepared to go through similar procedures, as it gears up to take on the US market.

Gover revealed that the CBD-based oral solution could be making its way to the United States in the near future. The company plans to file with the US Food and Drug Administration next year, followed by a European filing in 2018. “It [the results of the latest Epidiolex clinical trial] also means that the level of confidence we have in this product being filed with the US regulators and getting approved goes up another level,” explained Gover.

Earlier this year, GW Pharma announced positive results for a clinical trial that focused on Dravet Syndrome, a rare form of childhood epilepsy that currently affects 6,000 children across the country. The firm also intends on expanding its Epidiolex study to include patients suffering from Tuberous Sclerosis Complex, as well as behavioral conditions (autism and schizophrenia).

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