Cannabis Medicine To Treat Epilepsy Officially Approved By FDA

Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016

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.

The drug contains cannabidiol, or CBD, a substance derived from marijuana, but causes no intoxication, euphoria or "high", the FDA said. The drug, called Epidiolex, is an oral solution containing highly purified cannabidiol (CBD), which is one of scores of chemicals in the cannabis sativa plant, commonly known as marijuana.

Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse. Almost all patients with these conditions continue to have daily seizures-some having multiple per day-despite the use of legally available drugs.

"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said. Accordingly, before Epidiolex is ready for use amongst patients, it needs to be appropriately reclassified - something GW Pharmaceuticals expects to see happen within the next three months.

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. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician's care.

Carson says he will likely prescribe Epidiolex going forward.

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And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said. Only products that have received formal FDA approval can make such claims, typically requiring clinical trials costing millions.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market.

The FDA's decision was not unexpected, as the proprietary extract formulation - developed by the British biotechnology firm GW Pharmaceuticals - had previously demonstrated safety and clinical efficacy at reducing seizure frequency in several placebo-controlled trials.

A total of 30 US states, the District of Columbia, Guam and Puerto Rico allow the use of medical marijuana in some form, according to the US National Conference of State Legislatures.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. That decision is expected within 90 days. One in five patients is estimated to die before they are 20 years old. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances.

The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way. The AP is exclusively responsible for all content.

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