Published: Tue, June 26, 2018
Medicine | By Tracy Klein

FDA Approves Medicine Containing Cannabis for the First Time

FDA Approves Medicine Containing Cannabis for the First Time

The U.S. Food and Drug Administration has approved a marijuana-deriveddrug for the treatment of two rare and serious forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, that begin in childhood but can persist in adulthood.

A new drug derived from marijuana just became the first of its kind to get the green light from the USA government.

Now that Epidiolex is approved by the FDA, cannabidiol will probably be reclassified by the Drug Enforcement Administration within 90 days. It comes from a proprietary strain of cannabis grown by GW that has been bred to have high levels of CBD and low levels of THC, the component that does make people high. This drug does not contain THC, which is the part of the marijuana plant that would get someone high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.

"This is clearly a breakthrough drug for an terrible disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug. Researchers and advocates cautioned against this, however, with the caveat that it's impossible to verify that what's in those products is actually pharmaceutical-grade CBD.

He added, "This is how sound medical science is advanced".

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.

A government-regulated version of the oil will ease some doubts about the amount of CBD in the product, which can vary based on its origin, said Dr. Elaine Wirrell, director of the Mayo Clinic's child epilepsy program. The drugmaker is testing other CBD treatments for glioblastoma and schizophrenia.

Currently, some state laws prevent any cannabis-derived drug from being sold in pharmacies. "I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults". "There's no time line or clock that starts ticking on us".

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said. GW Pharmaceuticals grows the plants in the United Kingdom. But Garris highlighted that numerous side effects occur when it is taken with other medications, which she said is a concern because most patients are on other medications. Wall Street analysts have previously predicted it could cost $25,000 per year, with annual sales eventually reaching $1 billion.

The European Medicines Agency is expected to rule on the therapy in early 2019. The Figi family, whose daughter Charlotte was diagnosed with Dravet syndrome at 3 months old, has been extremely vocal about medical marijuana's merits.

Another 20 states allow medical marijuana, but the US government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

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