The FDA May Approve Its First Cannabis-Based Drug This Week
The FDA May Approve Its First Cannabis-Based Drug This Week
Marissa Parsons who has Lennox Gastaut syndrome visits the Grand Canyon with her family in 2016
26 June, 2018, 22:15
Today's approval "serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies".
Why? Because their product and company status will no longer exist in the legal gray area, and hopefully the mass confusion over which CBD products are legal and which are not will come to an end.
While most hemp-derived CBD companies are rapidly growing their businesses without repercussion or worry, many cannabis CBD businesses are hesitant about selling products in states where marijuana is not yet legal.
The drug, Epidiolex, is made up of cannabidiol (CBD), one of the hundreds of molecules found in the marijuana plant, and contains less than 0.1 percent of tetrahydrocannabinol (THC), the psychoactive component that makes people high.
Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections. But it's not quite medical marijuana.
"I preferred this to some of those other options because it's is a commercial product that has gone through rigorous testing", said Hendershot, who lives in Rochester, N.Y.
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.
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The FDA notes that it will still "take action" against illegal CBD products making "serious, unproven medical claims". She says this is a step forward for other families suffering all across the country.
"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said. British drugmaker GW Pharmaceuticalsexpects the oral solution to hit the market this fall.
A drug made from a derivative of marijuana has been approved for patients with certain forms of epilepsy.
GW Pharmaceuticals, the British company responsible for the drug, said now approved AEDs (anti-epileptic drugs) are not always effective in the majority of patients with Lennox-Gastaut Syndrome (LGS) and Dravet syndrome - severe forms of childhood-onset epilepsy. 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.
Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision. This treatment we have studied for the last five years.
Before sales of Epidiolex can begin, the DEA must formally reclassify CBD into a different category of drugs that have federal medical approval. And the company plans to continue importing the medicine, bypassing onerous US regulations on manufacturing restricted substances.
The European Medicines Agency is expected to rule on the therapy in early 2019.
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