BENGALURU – The US health regulator approved GW Pharmaceuticals Plc’s epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis.
The health regulator allows the drug’s to be used in patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy which are one of the most resistant to treatment.
Scott Gottlie whose the Food and Drug Administration commissioner 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.”
According to health officials the drug, Epidiolex, is a make of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, contains as little as 0,1% and even less in some cases of tetrahydrocannabinol (THC), the psychoactive component that makes people high.
GW Pharma the gcompany supply the drug grows its own supply of cannabis in specialised glass houses in the United Kingdom to ensure a assembly line in the genetic composition of the plants, which are then processed into a liquid solution of CBD.
However there side affects of THC it can induce paranoia, anxiety and hallucinations, but CBD has the opposite effect and scientists believe is a potential treatment for mental health issues.
Supporters of legalisation of marijuana say the decision is a step in the right direction, however businesses reliant on the plant must deal with the federal government’s ban on its use.
Because of the risk for potential abuse, the Drug Enforcement Administration (DEA) categorises chemicals into five schedules, with Schedule 1 substances – like marijuana and heroin – considered the deadliest and deemed to have no medical benefits.
This means Epidiolex’s launch remains in the hands of DEA.
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