First product derived from cannabis given US FDA nod

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

And now, as per Justin Gover, the CEO of GW Pharmaceuticals, the approval of Epidiolex is like a "historic milestone" adding that the drug will be the first ever FDA approved CBD medicine that will be used to treat two rare and severe forms of childhood epilepsy. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes. This approval is the culmination of GW's many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome. 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.

"The difficult-to-control seizures that patients with Dravet syndrome and Lennox-Gastaut syndrome experience have a profound impact on these patients' quality of life", said Billy Dunn, MD, the director of the FDA's division of neurology products, in a statement. The trials included 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. "Moreover, this is a purified form of CBD".

It has high mortality rate than other types of epilepsy and do not respond to any other drugs available.

The FDA's approval of this drug is highly newsworthy and will be of great interest not only for those seeking help for the rare seizure disorders the new drug, Epidiolex, is meant to treat, but also for other diseases and symptoms such as pain and nausea. 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". What's more likely is that the DEA reschedules CBD, while leaving THC and marijuana itself as a Schedule 1 substance. Some of the side effects of treatment with Epidiolex included, among other, sleepiness, lethargy, diminished appetite, rashes, and infections.

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Any further forays into the use of marijuana as medicine should go through the same process that produced FDA approval for Epiodiolex, he said. "This is the approval of one specific CBD medication for a specific use", Gottlieb said.

Stephen Schultz, vice president of investor relations for GW Pharmaceuticals, said the company expects to launch Epidiolex in the fall, pending scheduling from the DEA. For instance, a clinical trial is underway to test whether CBD can be an effective treatment for people with post-traumatic stress disorder and alcohol use disorder.

"This is an important medical advance". Marketing unapproved products, with uncertain dosages and formulations, can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.

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