On the 25th June 2018 the Food and Drug Administration approved Epidiolex that treats two rare forms of epilepsy.
Epidiolex from GW Pharmaceuticals is made of cannabidiol(CBD) and given as an oil, in clinical trials with patients diagnosed with Dravet or Lennox Gastaut syndromes the number of seizures have been seen to reduce by approximately 40%.
FDA Commissioner Scott Gottlieb said “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.”
Justin Gover from GW said in a statement “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.”
Before the product can hit the market the Drug enforcement Administration will have to reclassify CBD. This is expected within the next 90 days.
“This is an important medical advance,” Gottlieb said. “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.”
Source – statnews
Image – GWPharma