U.S. approves first marijuana-based medicine

Frederick Owens
June 27, 2018

The Food and Drug Administration is approving a marijuana-based medication to treat two rare seizure conditions associated with developmental issues.

Nasdaq-listed GW Pharmaceuticals, which grows its own marijuana plants in glass houses in Britain, hopes the drug will be approved in the United Kingdom next year.

Treatments available for both disorders are far from flawless 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.

The FDA says this is the first drug approved in the US that contains a purified substance derived from marijuana.

The drug's effectiveness was studied in clinical trials with 516 patients and when taken with other medications, Epidiolex was shown to be effective in reducing the frequency of seizures when compared with placebo. Last year, the FDA sent warning letters to a number of CBD manufacturers, demanding that they cease making "unproven" claims that their medicines can fight cancer.

He added, "This is how sound medical science is advanced".

Gottlieb noted that the action was "not an approval of marijuana or all of its components" but rather of one specific CBD medication for a particular use.

One key takeaway is that other drugs made with CBD now have a clearer path forward for federal approval. Epidiolex's approval also marks the first time the FDA has approved a drug to treat Dravet syndrome.

GW Pharmacueticals is expected to announce the USA launch for Epidiolex as soon as the DEA reclassifies CBD.

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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".

While the FDA had not previously approved any drug directly deriving from marijuana, it has marketed some containing a synthetic version of THC.

LGS and Dravet syndrome, which develop in childhood, are rare, severe forms of epilepsy that are notoriously treatment-resistant.

But although the green light means that patients will soon be able to access Epidiolex with a doctor's prescription, many will also likely turn to less expensive sources of CBD, such as those sold in marijuana dispensaries. But thanks to a cannabis extract dubbed Charlotte's Web, Zaki's seizures all but stopped entirely.

Based on the potential for abuse, the Drug Enforcement Administration (DEA) categorizes chemicals into five schedules, with Schedule 1 substances - like marijuana and heroin - considered the most deadly, and deemed to have no medical benefit whatsoever.

There have been several national news stories about parents exploring the treatment and it's worked.

In April, an advisory committee unanimously recommended approval of the drug for the two types of epilepsy.

A phase three clinical trial is underway for a third seizure-related condition called tuberous sclerosis complex, which begins in infancy and causes a sudden stiffening of the body, arms and legs, with the head bent forward.

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