USA approves first marijuana plant-derived drug for epilepsy

USA approves first marijuana plant-derived drug for epilepsy

USA approves first marijuana plant-derived drug for epilepsy

US health regulators on Monday approved the first prescription drug made from marijuana, a milestone that could spur more research into a drug that remains illegal under federal law, despite growing legalization for recreational and medical use.

While most hemp-derived CBD companies are rapidly growing their businesses without repercussion or worry, many cannabis CBD businesses are hesitant about selling products in states where marijuana is not yet legal.

Nine states plus Washington, D.C., have legalized medical marijuana, and the FDA said even more are considering it, particularly after it approved Epidolex. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex is the first licensed to treat Dravet syndrome. One 2015 study found that after three months of taking Epidiolex roughly 45% of patients saw a reduction in seizures.

FDA Commissioner Scott Gottlieb said the approval was "a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies". "But it's also important to note that this is not an approval of marijuana or all of its components".

The approval of Epidiolex may help open the door to more CBD research, as it helps to lift one regulatory hurdle.

Gottlieb also said the "path that made this possible" is "a path that's available to other product developers who want to bring forth marijuana-derived products through appropriate drug development programs". There are only a few pharmaceutical treatments for patients living with Lennox-Gastaut, no pharmaceutical options for those living with Dravet syndrome.

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GW Pharmacueticals is expected to announce the US launch for Epidiolex as soon as the DEA reclassifies CBD. "We'll continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims".

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", said the FDA.

Prior approval has been granted for medicines derived from synthetic cannabinoids. Some parents have used unapproved CBD oils to treat their children. 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 previous year in the New England Journal of Medicine. This would be historic as CBD would no longer be listed, alongside the marijuana plant itself, as a Schedule I drug with "no accepted medical use".

Before sales of Epidiolex can begin, the Drug Enforcement Administration must formally reclassify CBD into a different category of drugs that have federal medical approval.

"We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant", Armentano continued.

The FDA is not required to follow the advisory panel's advice but usually does. Another 20 states allow medical marijuana, but the USA government continues to classify it as a controlled substance with no medical use, in the same category as heroin and LSD.

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