First FDA-approved drug made from marijuana has N.J. ties

FDA Commissioner Scott Gottlieb said the agency "will continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products".

Epidiolex will become available in the fall, Gover told CNN. It is the fourth marijuana-based medicine to receive US FDA approval - joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). The drug is made of cannabidiol (CBD), a component of marijuana that doesn't give users a high.

Treatments available for both disorders are far from ideal and some patients resort to buying "self-prescribed" CBD online or from unregulated vendor sites, Dr. Pavel Klein, founder of the Mid-Atlantic Epilepsy and Sleep Center, said.

An advisory panel to the FDA recommended in April that the drug be approved.

"I'm really happy we have a product that will be much cleaner and one that I know what it is", said Dr. Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy. According to the New York Times, analysts expect Epidiolex to cost $2,500 to $5,000 a month. And, as NPR has reported, CBD supplements are available widely online and in dispensaries in the form of oils or tinctures. Most producers say their oil is made from hemp, a plant in the cannabis family that contains little THC and can be legally farmed in a number of states for clothing, food and other uses.

Gottlieb hinted at additional enforcement actions against companies that sell unregulated CBD products with medical claims that aren't backed up by evidence.

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There are likely to be drug interactions, she said, but "that's not uncommon for antiepileptic medications", and she noted that this could affect the effectiveness of the medication.

"Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", he said.

For a maligned substance like cannabis, I think the vindication tour will ultimately be years long. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Epidiolex contains CBD, a cannabis chemical compound skyrocketing in popularity and driving what is estimated to have doubled into a $200 million market in 2018.

A mother feeds her epileptic son, whom she treats with medical marijuana, in Siedlce, Poland, in October 2017. In one study of 120 children and young adults with Dravet syndrome, cannabidiol reduced the median frequency of convulsive seizures to 5.9 a month from 12.4 before treatment, while patients getting a placebo saw minimal reductions, according to results published a year ago in the New England Journal of Medicine. The agency is expected to do so within 90 days.

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.

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