Monday, 19 November, 2018

FDA approves first marijuana based drug

FDA approves first ever drug derived from marijuana | TheHill FDA Approves First Drug Derived From Marijuana Plant
Alonzo Parks | 28 June, 2018, 11:21

This two-phase trial has proved to be highly effective in treating children detected with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) - two severe and rare forms of epilepsy, for the patients aged 2 years and above.

FDA approves marijuana-derived drug, the prescription cannabidiol medicine to treat seizures in a subset of patients suffering from rare and severe epilepsy.

Epidiolex is an oral CBD-based medicine for the treatment of Lennox-Gestaut syndrome and Dravet syndrome, two conditions that begin in infancy and childhood and are characterized by varying and difficult-to-control seizures.

Jackson's group estimates the typical family using CBD to treat childhood epilepsy spends about $1,800 per year on the substance. The new approval is already ushering in a wave of renewed interest in the potential health benefits of marijuana's many compounds, from CBD to THC - the plant's other well-known ingredient and the one linked with a high. Unfortunately for both conditions it is estimated that 1 in 5 patients will die before reaching the age 20.

Gottlieb noted that this is "purified CBD Oil", meaning that there are not any elements from the marijuana plant within the approved drug that can get you high.

Marijuana has always been known to be effective in reducing the frequency of seizures in some patients; and many patients buy medical grade marijuana in states where it is legal as treatment.

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FDA officials said the drug reduced seizures when combined with older epilepsy drugs.

The DEA's stance that any extract from the Cannabis sativa plant is classified as Schedule I was recently upheld by the 9th U.S. Circuit Court of Appeals. Some of the side effects of treatment with Epidiolex included, among other, sleepiness, lethargy, diminished appetite, rashes, and infections.

The decision follows a unanimous vote in favour of the approval by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee. "And, the FDA is committed to this kind of careful scientific research and drug development", said FDA Commissioner Scott Gottlieb.

Justin Gover, CEO of GW Pharmaceuticals, the UK-based company behind the drug, said the approval signals "validation of the science of cannabinoid medication". But that is not necessarily the case and readers with an interest in this drug would be better informed if some of the clinical trial evidence had been included in the story. GW won't be able to market Epidiolex until the DEA reclassifies CBD. Indeed, the FDA has been trying to crack down on CBD producers who make claims that their products can cure diseases like cancer.

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".

"Today's approval demonstrates our commitment to the scientific process and working with product developers to bring marijuana-based products to market", he said.

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