On Monday, the Food and Drug Administration approved the country’s first drug derived from marijuana.
The drug, GW Pharmaceuticals’ Epidiolex, treats two different forms of epilepsy, according to StatNews. Consisting of cannabidiol (CBD), which doesn’t elicit a high among users, it will be sold as an oil, and demonstrated its success in trails where it reduced seizures by 40% in patients with Dravet or Lennox-Gastaut syndromes.
FDA Commissioner Scott Gottlieb stated, “This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And the FDA is committed to this kind of careful scientific research and drug development.”
GW CEO Justin Gover added, “This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”
He added:
This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”
Before Epidiolex can be sold, the Drug Enforcement Administration will have to reclassify CBD, considered a Schedule I drug. That ruling should happen in the next 90 days.
Lennox-Gastaut and Dravet syndromes can cause recurrent seizures, even dozens in one day; 20% of patients suffering from the diseases die before they are 20 years old.