FDA approves first marijuana-based prescription drug

Epidiolex a medicine made from the marijuana plant but without THC

Epidiolex a medicine made from the marijuana plant but without THC

Indianapolis, In. - Attorney General Curtis Hill today praised the process by which the U.S. Food and Drug Administration for the first time has approved a cannabis-based drug - Epidiolex.

Epidiolex is a twice daily oral solution which has been approved to be used in patients aged 2 years and above and suffer with severe Dravet epileptic syndrome or Lennox-Gastaut epileptic syndrome.

"The FDA's approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis", said NORML Deputy Director Paul Armentano.

Beyond the U.S., the medicine is now under review by the European Medicines Agency for the treatment of seizures in patients with Lennox-Gastaut or Dravet syndrome.

Anup Patel, M.D., chair of the LGS Foundation's professional advisory board, chief of neurology at Nationwide Children's Hospital and study investigator, says, "I am very pleased to see the FDA's approval of EPIDIOLEX® for LGS and Dravet syndromes". According to pharmacists, it does not contain THC, which is the ingredient that gives recreational users of marijuana a high.

Epidiolex is made from purified CBD and developed by GW Pharmaceuticals, a UK-based company that has grown cannabis legally under licence from the UK Home Office in order to carry out research.

The drug is the only treatment officially approved to treat Dravet syndrome. FDA staff said at an April meeting on the drug with outside advisers that cannibidiol, known as CBD, "does not appear to have abuse potential".

In the press announcement, FDA stated that Epidiolex must be dispensed with a patient Medication Guide that details information about the drug's uses and risks.

GW Pharma will make Epidiolex in the United Kingdom, where the company is based, Gover said, and export the finished product to the US. "This is how sound medical science is advanced".

Here's how FDA Commissioner Scott Gottlieb put it: "It's also important to note that this is not an approval of marijuana or all of its components".

The most common side effects from the drug were sleepiness, diarrhea, insomnia, elevated liver enzymes cause mild liver injury and infections. The company has not yet set a price for the drug and said it would work with insurance providers to ensure the medicine would be covered under health plans. An EMA decision on whether to recommend approval is expected in the first quarter of 2019.

"It wouldn't have as full of a cannabinoid panel as Charlotte's Web hemp oil has, and so we would really need to think long and hard about switching her from a natural product to a pharmaceutical CBD", Gaer said.

He said, "Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

Many are hoping that the FDA's approval of Epidiolex will shed light on this confusing problem.

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