For the first time ever, the U.S. Food and Drug Administration (FDA) has put its seal of approval on an oral cannabidiol (CBD) solution that will be prescribed to patients suffering from rare and severe cases of epilepsy.
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. Where is weed legal?
The drug contains nearly non of the psychoactive chemical from marijuana that makes people high and proved through testing to be effective in treatment of certain pediatric seizure patients.
"This is clearly a breakthrough drug for an terrible 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. But it's not quite medical marijuana. Nevertheless, we're encouraged that the Epidiolex approval will bring more and more research interest and funding to cannabinoid based therapies that have the potential to provide significant changes to consumers' lives.
Jackson's group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance.
Physicians say it's important to have a consistent, government-regulated version.
It is a development that FDA Commissioner Scott Gottlieb said, "serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".
Treatments available for both disorders are far from ideal and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said.
Lennox-Gastaut syndrome and Dravet syndrome are both rare conditions that develop in childhood involving frequent seizures.
He said the FDA would review legitimate applications for approval but said the agency needed solid scientific studies that demonstrate whether a product actually works and is safe. 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.
One key takeaway is that other drugs made with CBD now have a clearer path forward for federal approval. From Walmart to CVS to the Mom-n-Pop drugstores still kicking it Smalltown, USA - legitimate cannabis medicine will be available in the same way as other prescription drugs. Before the panel meeting, FDA staff also backed the drug in their own report, saying the company offered "substantial evidence" of efficacy.
For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market.
GW Pharmacueticals is expected to announce the USA launch for Epidiolex as soon as the DEA reclassifies CBD.
The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education.