The first marijuana-derived drug gets FDA nod for prescription in the US
From November 1, doctors in all 50 states of the US, can legally prescribe an FDA-approved drug that contains compounds found in cannabis.
The new medicine named Epidiolex from GW Pharmaceuticals will be used to treat two rare and severe forms of epilepsy. Epilepsy is a neurological disorder that leads to unpredictable seizures. The oral solution is to be taken twice daily.
Side effects include thoughts of suicide, aggression, panic attacks, depression (new or worsening) and agitation
Epidiolex, fruit-flavored liquid contains cannabidiol, the chemical compound also known as CBD. It is increasingly popular for its reported abilities to deliver relief from maladies such as anxiety, joint pain, insomnia, and nausea. The medication does not contain tetrahydrocannabinol, marijuana’s primary psychoactive component that causes the common “high.”
While Epidiolex is approved specifically for treating two potentially fatal forms of severe childhood epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, there’s a good chance it will be prescribed for “off-label” use.
Scientists behind the drug studied Epidiolex’s effectiveness in three randomized, double-blind, placebo-controlled clinical trials with a total of 516 patients, all of whom suffered with one of the two epilepsy conditions.
Orrin Devinsky, lead investigator of two of the three clinical trials, said “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,”
“There are some people who had dramatic improvements. Many had a modest improvement, and some had no improvement,” he added. “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.”
The most serious risks of the drug include thoughts of suicide, aggression, panic attacks, depression (new or worsening) and agitation. Side effects may also raise possibility of rare but more severe liver injury.