Published: Вт, Июня 26, 2018
Medical | By Marta Holmes

FDA approves first ever drug derived from marijuana


The US Food and Drug Administration announced today, Monday June 25, the approval of the country's first marijuana-based prescription medication. The drug is made of cannabidiol (CBD), a component of marijuana that doesn't give users a high. 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 past year in the New England Journal of Medicine. According to the agency's website, the FDA "is aware that there is considerable interest in [marijuana's] use to attempt to treat a number of medical conditions, including, for example, glaucoma, AIDS wasting syndrome, neuropathic pain, cancer, multiple sclerosis, chemotherapy-induced nausea, and certain seizure disorders". 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.

A flowering marijuana plant is pictured at the Canopy Growth Corporation facility in Smiths Falls, Ontario, Canada, January 4, 2018. The current status as a Schedule I drug presents unresolved regulatory risk for Epidiolex.

In Ohio, a bill in the Senate would remove drug schedules from state law and instead have the state pharmacy board schedule substances in rules and regulations. They're defined as substances with high abuse potential and "no now accepted medical use". They're not regulated the way pharmaceutical drugs are, so the consistency and dose can vary widely.

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it.

Ironically, an advisory panel for the FDA unanimously approved the recommendation for Epidiolex one day before 4/20.

The DEA did not immediately respond to Ars' request for comment.

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GW said it expects the reclassification to occur within 90 days.

The oral drug Epidiolex is intended for patients to treat two rare, and severe forms of epilepsy-Lennox-Gastaut syndrome and Dravet syndrome.

Epidiolex is essentially a pharmaceutical-grade version CBD oil, which some parents already use to treat children with epilepsy.

Still, this approval comes as the White House is said to be reconsidering federal prohibition of marijuana and as more and more states approve it for recreational and medicinal use. CBD oil and infused products have popped up on health food and grocery store shelves. A study at the end of a year ago found that almost 70 percent of CBD products sold online were mislabeled.

British drugmaker 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.

We'll 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.

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