First Cannabis-Based Drug Approved by FDA Now Available

First Cannabis-Based Drug Approved by FDA Now Available

By visivastudio

photo credit: visivastudio // Shutterstock

The FDA has just approved its first cannabis-based medication, Epidolex, and it is now available in all 50 states.

The oral medication can safely be taken by patients 2-years-old or older who suffer from two types of epileptic syndromes : dravet syndrome, a rare genetic disfunction of the brain that begins in the first year of life, and Lennox-Gastaut syndrome, a form of epilepsy with multiple types of seizures that begins in early childhood, usually between ages 3 and 5.

Justin Gover, the CEO of GW Pharmaceuticals, the creator of Epidolex, tells CNN that history shows these patients typically do not respond well to seizure medications currently available, resulting in the dire need for new therapies that can reduce the frequency and impact of seizures.

Being approved by the FDA in June cleared the final path for doctors in the U.S. to legally prescribe the drug to patients.
“In those syndromes, when [Epidiolex] was added to three other seizure [medications], on average, it reduced convulsive seizures — or ‘drop seizures’ — by about 25% to 28% compared to a placebo,” Devinsky said. “So I think it’s very important to recognize … that it clearly is effective, and this was statistically significant in all three of the large studies that we did, but by the same token, the effect was modest.”
“There are some people who had dramatic improvements. Many had a modest improvement, and some had no improvement. So it’s not a miracle drug. It’s an effective drug, and I think its side effect profile is quite good compared to other seizure drugs that we have, but it’s not a miracle cure,” Devinsky said.
Written by Clarke Jones