According to GW Pharmaceuticals, the United States Drug Enforcement Administration (DEA) will have to reclassify CBD before Epidiolex can be made available to patients. The confusion lies in understanding the difference between CBD and THC. No clinical trials have proved that CBD can treat specific diseases.
The FDA still hasn't given its blanket approval to marijuana as a "safe and effective drug", though it has OK'd three medications that contain synthetic compounds similar to those found in the marijuana plant.
It is important to point out that GW Pharmaceutical's CBD solution Epidiolex is higher-quality medicine than the majority of the CBD products sold on the Internet and through various health food stores.
Earlier this year, an FDA advisory panel unanimously recommended that the FDA approve Epidiolex, in large part due to strong research data and evidence of the drug's effectiveness in controlling the violent drop seizures that accompany two rare forms of childhood epilepsy. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them.
The FDA's decision was not unexpected, as the proprietary extract formulation - developed by the British biotechnology firm GW Pharmaceuticals - had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials. The trial lasted 14 weeks.
The drug has been shown to reduce seizures and return a few children to near-normal function.
Given that CBD is an ingredient in marijuana, people often confuse it with taking "regular" marijuana. "Yet we were surprised at how robust the response was in this study", Dr. Anup Patel, a pediatric neurologist at Nationwide Children's Hospital in OH and one of the lead authors of the study, told ABC News.
Dravet syndrome typically becomes apparent during the first year of life and is marked by frequent seizures as well as weak language and motor skills, hyperactivity and social difficulties. Researchers enrolled 120 children and young adults to compare Epidiolex to standard anti-epileptic treatment.
Epidiolex was approved for patients age 2 and older who suffer from Lennox-Gastaut and Dravet syndromes.
There are side effects, the most common being sleepiness, Gover said.
"I'm really happy we have a product that will be much cleaner and one that I know what it is", Wirrell told the Associated Press. But unlike tetrahydrocannabinol, or THC, it does not produce a high. It may also have far-reaching implications for USA marijuana policy.
When can parents of children with LGS or Dravet syndrome access Epidiolex? A prescription drug provides a workaround to this issue.
This means Epidiolex, which will require a prescription from a doctor, will soon be available in pharmacies all across the nation. The agency now has 90 days to reschedule CBD from its rank as a Schedule I drug on the Controlled Substances Act.
The FDA's Scott Gottlieb did the honors in the statement today, celebrating GW for the work they did, and warning anyone else against trying to market cannabis-related products with dubious support for their claims.