Published: Wed, June 27, 2018
Health Care | By Oscar Goodwin

FDA approves first marijuana-derived drug- and it may spark DEA rescheduling

FDA approves first marijuana-derived drug- and it may spark DEA rescheduling

Fox hailed Monday's FDA action as a win for the broader medical marijuana community, in that it will facilitate more clinical research into the drug's medical benefits.

On Monday the agency approved its first marijuana-derived drug, Epidiolex, for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, two rare forms of pediatric epilepsy.

GW Pharma $GWPH finished its layup at the FDA today with Epidiolex, grabbing its first ever marketing OK for one of its cannabinoid drugs and setting up the biotech for a major shift toward commercialization. Where is weed legal?

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. Gover said the green light signifies that his company's recent efforts in developing more drugs from marijuana's compounds (also known as cannabinoids) finally have a concrete path forward.

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Marijuana now has an accepted medical use. It is the fourth marijuana-based medicine to receive US FDA approval - joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros). The CBD oil derived from the marijuana plant has been administered to relieve insomnia, anxiety and chronic pain, as well as to treat multiple sclerosis and Parkinson's disease, among conditions, wrote Harvard Medical School professor Dr. Peter Grinspoon.

Physicians say it's important to have a consistent, government-regulated version.

Shlomo Shinnar, president of the American Epilepsy Society and a neurologist at Montefiore Medical Center in NY, has said the drug will be "a very valuable addition" to the limited options for treating severe childhood-onset epilepsy. 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.

FDA Commissioner Scott Gottlieb said the approval was "a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".

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DENVER ― Medical marijuana now comes with the FDA seal of approval.

Several parents of children with epilepsy testified before the panel, saying cannabidiol helped reduce seizures and improve quality of life. "This is the approval of one specific CBD medication for a specific use", Gottlieb said.

While this move will undoubtedly increase profits for GW Pharmaceuticals, predicting annual sales eventually reaching $1 billion, it could also bring some much-needed relief to hundreds of thousands of children afflicted with more complex variations of epilepsy for which traditional treatments have been mostly ineffective. The company expects this to happen in the next 90 days. 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.

The Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education.

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