U.S. Approves First Marijuana-Based Plant-Derived Drug for Epilepsy
WASHINGTON — June 27, 2018
It was done in order to win legal approval open the floodgates for more research into the medicinal properties of cannabis, according to a US health regulator.
This will be used for an objective assessment on the impact on the health and treatment of patients aged two years and older with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS), rare childhood-onset forms of epilepsy.
“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,” said Food and Drug Administration Commissioner Scott Gottlieb.
The drug is made of cannabidiol, one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1% of tetrahydrocannabinol (THC), the psychoactive component that makes people high.
Although THC can induce paranoia, anxiety and hallucinations, CBD has the opposite effect and has been cited by scientists as a potential treatment for mental health issues.
British drug maker GW Pharmaceuticals studied the drug in more than 500 children and adults with hard-to-treat seizures, overcoming numerous legal hurdles that have long stymied research into cannabis.
FDA officials said the drug reduced seizures when combined with older epilepsy drugs. FDA chief Scott Gottlieb said his agency had supported research on cannabis-derived products "for many years."
"This approval serves as a reminder that sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies," Gottlieb told reporters.
Side effects of new drug include diarrhea, vomiting, fatigue and sleep problems.
According to scientists, we must also bear in mind the threat posed by marijuana and heroin - considered the most deadly and deemed to have no medical benefits. "Last year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health." they said in statement.
Nine US states and the District of Columbia have legalized marijuana for recreational use. Another 20 states allow medical marijuana, but the U.S. government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.