Today's approval "serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies". As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire. Despite the medication's approval, cannabis remains a Schedule I substance, which, according to the federal government, means it has "no accepted medical uses".
For those who have long argued that cannabis offers medical benefits, the FDA approval represents a milestone, "a recognition that the plant is a rich source of compounds which have potential therapeutic activity", Justin Gover, chief executive of GW Pharmaceuticals, the London-based company that developed the drug, said in an interview last week.
That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained.
Ohio's medical marijuana law allows people with one of 21 medical conditions to buy and use medical marijuana if recommended to them by a physician. The drugmaker is testing other CBD treatments for glioblastoma and schizophrenia.
"I don't know a mom or dad in their right mind who is going to change what's already working", said Heather Jackson, CEO of Realm of Caring, a charitable group affiliated with Colorado-based CW Hemp, one of nation's largest CBD companies.
The FDA notes that it will still "take action" against illegal CBD products making "serious, unproven medical claims".
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. This drug does not contain THC, which is the part of the marijuana plant that would get someone high. The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters. The FDA has approved the first medication containing marijuana for patients with rare forms of epilepsy.
The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the USA subsidiary of GW Pharmaceuticals.
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. "And, the FDA is committed to this kind of careful scientific research and drug development", Dr. Gottlieb said.
She says 17 doctor-prescribed drugs didn't help her son. Accordingly, before Epidiolex is ready for use amongst patients, it needs to be appropriately reclassified - something GW Pharmaceuticals expects to see happen within the next three months.
Experts are hopeful that the approval will unleash a wave of new interest in the potential medical applications of CBD and other marijuana compounds. Past year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health. 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.