Medicine

For first time ever, FDA approves marijuana-derived medicine

For first time ever, FDA approves marijuana-derived medicine

A new drug derived from marijuana just became the first of its kind to get the green light from the U.S. government. The Drug Enforcement Administration is expected to reclassify CBD, allowing prescriptions of Epidiolex.

Epidiolex, manufactured by GW Pharmaceuticals in the United Kingdom, is made from cannabidiol, the non-psychoactive part of the cannabis plant. That so-called "high" comes from a different compound in marijuana, known as tetrahydrocannabinol (THC). The British drugmaker studied the drug in more than 500 patients with hard-to-treat seizures, overcoming numerous legal hurdles to conducting research with cannabis.

"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. 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.

Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy. 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.

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

Several years ago, Allison Hendershot considered relocating her family to Colorado, one of the first states to legalize marijuana and home to a large network of CBD producers and providers.

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And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said.

He added: "We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant. There's no time line or clock that starts ticking on us". "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

A GW Pharmaceuticals spokeswoman said the company would not immediately announce a price for the drug, which it expects to launch in the fall. The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market. That decision is expected within 90 days.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care.

The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year.