"However, we remain concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims".
The US Food and Drug Administration announced today, Monday June 25, the approval of the country's first marijuana-based prescription medication.
While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case. It comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC, the component that does make people high.
British drugmaker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis. 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".
"The DEA will need to make a different scheduling decision for CBD.because it now has an accepted medical use", he said during a conference call with reporters.
The drug's approval permits its use in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy that are among the most resistant to treatment.
CBD is the common abbreviation for cannabidiol, a chemical derived from cannabis.
Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy.
"Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes", Gottlieb said.
Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.
"I preferred this to some of those other options because it's is a commercial product that has gone through rigorous testing", said Hendershot, who lives in Rochester, New York. 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).
Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer "drop" seizures - in which her entire body goes limp and collapses. GW Pharmaceuticals grows the plants in the United Kingdom.
The medicinal acknowledgment of CBD should come as good news to marijuana startups eyeing the compound for consumer and medical consumption. The decision caps decades of work by the company to gain approval in the US for a medicine derived from the cannabis plant. The agency is expected to do so within 90 days.
The European Medicines Agency is expected to rule on the therapy in early 2019.