GW Pharmaceuticals’ cannabis-derived Epidiolex showed “high statistical significance” in its third late-stage clinical trial in the U.S., meaning it’s shaping up to be an extremely effective treatment for patients with epilepsy, according to a report from the Telegraph.
The recent study tested the drug’s value for children and adults diagnosed with Lennox-Gastaut syndrome, characterized by impaired intellectual functioning, developmental delays, and dozens or seizures per month.
The successful trial puts the Britain-based company on track to file the drug with the FDA in the first half of 2017. According to Reuters, if it is approved it would become the first drug sanctioned by the FDA to be made from organic cannabis. The company will be able to submit the drug for two different types of epilepsy due to an agreement with the FDA, and a European launch of the drug would likely follow an approval in the U.S.
“As a body of data we now have three positive phase three trial results,” Justin Gover, GW chief executive, said in the Telegraph report. “These are very robust findings and provide a compelling case to support the efficacy and safety of the drug with US regulators.”
The company has been collecting funds in anticipation of the launch. In July, it added $300 million from U.S. investors, and it has earmarked about $500 million to help fund the rollout of Epidiolex in the states.
The Children’s Hospital Network in Australia is also conducting trials of the drug.
To learn more about how cannabinoids and the endocannabinoid system can be used to treat epilepsy, you can hear it explained by cannabis researcher Dr. Ethan Russo — formerly Senior Medical Advisor for GW Pharmaceuticals — on the Ganjapreneur Podcast.