A hardcore researcher from Cincinnati is credited with getting Epidiolex approved by the U.S. Food and Drug Administration. Dr. Michael Privitera, who specializes in brain seizures, ran a clinical study of the drug that was so successful, the USDA approved it. It’s the first time a marijuana-based medicine has been ever been granted FDA approval.
Privitera calls it “historic,” telling Cincinnati.com:
We did the right kind of science. We took the anecdotal evidence, extracted the substance in marijuana that helps, tested it, and we followed the testing guidelines used for every other drug. This study really proves it, and we can make sure it’s safe.
Privitera, who founded and directs the Epilepsy Center at the UC Gardner Neuroscience Institute, decided to study Charlotte’s Web oil — a high-CBD strain effective for seizures — after reading about, deciding it couldn’t hurt if it meant potentially helping patients.
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At the same time, one of Privitera’s friends, Dr. Orrin Devinsky, of New York University Langone Comprehensive Epilepsy Center, was launching an experiment of his on own to see the effects of a pure-CBD oil manufactured by GW Pharmaceuticals. According to Cincinnati.com:
One group of study subjects would get a low dose of Epidiolex. One group got a high dose. A third got a placebo. Neither doctors nor patients would know who was getting what. The hope was to put the brake on Lennox-Gastaut syndrome, which triggers terrifying “drop seizures” that mash the halt button in the brain. The body locks up, and gravity takes over, often resulting in disabling head injuries.
Privitera got UC included on the study that GW Pharmaceuticals was paying for, knowing that both the FDA and U.S. DEA would be watching. He told Cincinnati.com, “I didn’t realize what I was signing up for. I’ve been doing this work for 30 years, and this was far and away the most complicated and difficult study we’ve ever had to do.”
According to Cincinnati.com, every “i” had to be dotted and “t” crossed for this experiment to pass the feds:
To participate in the study, Privitera first needed a Schedule I license, which required a nine-month review including fingerprinting.
The drug could only be dispensed from the address on Privitera’s Schedule I license, the Medical Arts Building.
The DEA would only examine records there, too, so at every audit, nurse coordinator Donna Schwieterman rolled a full file cart from Privitera’s office in the Stetson Building to the Medical Arts Building across busy Martin Luther King Boulevard.
Privitera had to account for every drop of Epidiolex. Every bottle that left the building had to be returned, empty or not. Privitera had to hire a disposal company to collect and destroy the bottles and any leftover oil.
The results of Privitera’s study were published this past May in the New England Journal of Medicine. The results? According to Cincinnati.com, “the average reduction in drop seizures was 37 percent at a 10mg dose and 41 percent at a 20mg dose. Even the placebo patients had a 17 percent reduction. In some patients, Privitera said, the decrease was as high as 90 percent.”
The most serious side effects were sleepiness, reduced appetite and diarrhea.
A month before the study was published, an FDA review committee unanimously voted to recommend approval of the drug. And earlier this week (June 25), the final approval was handed down, which means Epidiolex could be in pharmacies by the end of 2018.
