Sativex hasn't been granted approval in the United States, however.
Epidiolex is actually made by extracting the CBD molecule from cannabis plants and isolating it, Stephen Schultz, a spokesperson for GW Pharmaceuticals, which makes the drug, tells Yahoo Lifestyle. It is the fourth marijuana-based medicine to receive US FDA approval - joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). According to the agency's website, the FDA "is aware that there is considerable interest in [marijuana's] use to attempt to treat a number of medical conditions, including, for example, glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders".
"This is clearly a breakthrough drug for an bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.
The medication needs to go through several more steps before it's available as a prescription.
"The FDA prepares and transmits... a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the [Controlled Substances Act]", the FDA stated, indicating that it will recommend that CBD be rescheduled but the act of shifting the substance's legality is ultimately in the DEA's hands. And even the ones that do are far from having the blessing of the federal government, and therefore are not covered through any insurance network. After considerable public pressure, the Home Secretary used an "exceptional power" to enable a 12-year-old boy to be treated with a batch of a banned drug that had been seized from the boy's mother on her return from Canada to the UK. And thank for ganja gods for that - a report from the Associated Press indicates that patients could spend in upwards of $25,000 per year on this medicine.
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. What's more, the DEA will reportedly reschedule CBD in light of the FDA's decision, greatly loosening restrictions on research. The company expects this to happen in the next 90 days. The non-intoxicating compound now falls in line with marijuana, which has "no now accepted medicinal use" in the eyes of Uncle Sam.
This reschedule should make it easier for researchers to study CBD for its potential health benefits. This compound will remain in the same ranking as heroin. Epidiolex is a pharmaceutical-grade formulation; the approval was granted to GW Research Ltd.
Relying on homemade oil "is is a awful system, creating products that likely have more variability and can potentially contribute to more side effects and less consistency", Devinsky said. Hemp versions of this product are lucky to hit 3.5 percent CBD.
Now with the approval of Epidiolex, a drug that will not produce an euphoric "high" feeling in the user - Devinsky said he expected CBD would be moved down to a schedule 4 or 5 drug, which is one that poses a low potential for abuse and dependence.