ibusinesslines.com November 21, 2018

FDA greenlights GW's Epidiolex, the first U.S. drug made from marijuana

26 June 2018, 10:17 | Melissa Porter

FDA Approves First Cannabis Based Drug

FDA Approves First Cannabis Based Drug

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", said FDA Commissioner Scott Gottlieb during a call with reporters about the approval. As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire. This is the approval of one specific CBD medication for a specific use.

While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.

Ohio's medical marijuana law allows people with one of 21 medical conditions to buy and use medical marijuana if recommended to them by a physician.

Still, Jackson is glad that her family's experience could now provide new treatment options for other childhood seizure sufferers.

There are likely to be drug interactions, she said, but "that's not uncommon for antiepileptic medications", and she noted that this could affect the effectiveness of the medication. The medication has been approved for patients aged two years or older and marks the first time the agency has approved a drug derived from cannabis.

He said the FDA would review legitimate applications for approval but said the agency needed solid scientific studies that demonstrate whether a product actually works and is safe. Carreno says that a leader drug like Epidiolex often paves the way for other less expensive-and untested-CBD products. This drug does not contain THC, which is the part of the marijuana plant that would get someone high.

The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals.

Patients, parents of children suffering from severe epilepsy, and some researchers have long suspected CBD's potential to treat the devastating seizure disorders.

"This is clearly a breakthrough drug for an very bad disease", John Mendelson, a panel member and senior scientist at the Friends Research Institute, said at a public FDA meeting this spring that was called to discuss the scientific merits of the drug.

Dravet syndrome is a rare genetic condition that causes frequent fever-related seizures, involuntary muscle spasms and a potentially life-threatening state of continuous seizure activity requiring emergency medical care.

Despite increasing acceptance, there is little rigorous research on the benefits and harms of marijuana. We've known for years that cannabidiol is a powerful cannabinoid with legitimate and proven medical properties.

Many companies sell cannabis-based treatments, touting them as cancer cures, pain relievers and anxiety medicines. The company expects this to happen in the next 90 days. European approval is expected in early 2019.

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