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FDA approves first ever drug derived from marijuana

FDA approves first ever drug derived from marijuana | TheHill

For the first time, the FDA approved a drug derived from the marijuana plant, and it could help patients with rare forms of epilepsy.

According to GW Pharmaceuticals, the United States Drug Enforcement Administration (DEA) will have to reclassify CBD before Epidiolex can be made available to patients.

More research is still necessary for medical professionals to draw any firm conclusions about CBD's potential to treat seizure conditions. Epidiolex contains only cannibidiol, one of hundreds of molecules found in the marijuana plant, and treats only two extremely rare forms of pediatric epilepsy affecting less than 45,000 children.

The drug contains nearly non of the psychoactive chemical from marijuana that makes people high and proved through testing to be effective in treatment of certain pediatric seizure patients.

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.

It is a development that FDA Commissioner Scott Gottlieb said, "serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies". It also marks a landmark moment in the agency's advancement in considering cannabis for medical purposes. "But it's also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use", Gottlieb said. "If the FDA makes it clear that a cannabis-based pharmaceutical drug has medicinal value, then Congress can no longer claim there is no medicinal quality for cannabis".

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A total of 225 patients suffering from Lennox-Gastaut syndrome were divided into three groups. That decision is expected within 90 days.

Research has shown that CBD has the potential to treat seizure conditions, like Dravet syndrome.

The Drug Enforcement Administration (DEA) classifies marijuana or cannabis as a Schedule 1 substance - which means there is "no now accepted medical use and a high potential for abuse". "However, it remains to be seen whether physicians will be comfortable prescribing this new agent to those patients who may benefit from it, and whether it will be priced in a range that patients may afford".

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.

An external FDA advisory panel recognized as much when it stated in April that cannabidiol would need to be rescheduled before legal sales of Epidiolex could begin. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder. Cannabis-derived CBD products are available where recreational marijuana is sold, though CBD derived from industrial hemp faces fewer regulations and is even stocked by some grocery stores.

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