Cannabis grown in UK used in FDA approved epilepsy drug

AP  File 2017		GW Pharmaceuticals’ Epidiolex a medicine made from the marijuana plant

AP File 2017 GW Pharmaceuticals’ Epidiolex a medicine made from the marijuana plant

Epidiolex contains cannabidiol (CBD), a chemical component of the cannabis sativa plant, more commonly known as marijuana.

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", the FDA said. Although it's only approved for two types of epilepsy, doctors could legally prescribe it for other forms of epilepsy and even non-seizure problems like chronic pain.

"Based on numerous clinical trials, this medication may help meet the need for this specific paediatric patient population and is now the first to be approved by the FDA in Dravet syndrome".

"This approval serves as a reminder", Scott Gottlieb, the FDA commissioner, said in a statement on Monday, "that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".

Despite these studies showing that the treatment reduced the number of seizures in patients, when compared with placebo, there had still been no precedent to date to indicate how the FDA would react to the application.

But Dr. Gottlieb also held out the possibility of more approvals for marijuana-based drugs down the road.

Despite today's approval, the FDA acknowledged in a statement that the cannabidinoid CBD still remains classified at this time as a schedule I controlled substance, and that the agency is "prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims". Almost all patients with these conditions continue to have daily seizures-some having multiple per day-despite the use of legally available drugs. GW Research Ltd., the London-based company who produced Epidiolex is also expecting another decision that will require reclassifying CBD and allowing other marijuana-derived medications as well as reducing limitations on marijuana-related research. However, it isn't clear whether such a reclassification would involve CBD products in general, the CBD formulation used specifically in Epidiolex or something else.

The FDA said the action isn't an approval of overall marijuana use, even if it's meant to treat other illnesses, but pharmacists said the FDA's decision could lead to more marijuana-derived drugs.

The us health regulator approved the first drug made with marijuana. The drug will be marketed under the brand name Epidiolex. Just a few months ago, news broke of a very encouraging FDA panel assessment, which indicated a positive outlook for the drug's approval.

"Now that the FDA is on board we can really untap a resource that people have been steering away from for far too long", Defran said.

Gaer said she's been using a particular CBD oil with her daughter since it's been legal in Iowa, and she's not sure about this new drug.

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