Health Care

Cannabis grown in United Kingdom used in FDA approved epilepsy drug

Cannabis grown in United Kingdom used in FDA approved epilepsy drug”

This drug is a treatment option of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. "And the FDA is committed to this kind of careful scientific research and drug development", Gottlieb concluded.

The FDA's decision was expected.

Some have said that they have no intention of switching to the new prescription CBD drug because the products they're using are helping their children.

Critically, the drug will be available to patients nationwide, not just in states where cannabis is legal for medical purposes.

Epidiolex is manufactured by the British firm GW Pharmaceuticals, which funded the clinical trial.

GW said it expects the reclassifying to occur within 90 days.

"Our families have been waiting for this exciting announcement", CEO of Epilepsy Foundation Central and South Texas, Sindi Rosales said.

A company representative said the list price for the medication had not been set yet.

An estimated 30,000 children and adults suffer from Lennox-Gastaut syndrome, and fewer from Dravet syndrome.

A new drug derived from marijuana just became the first of its kind to get the green light from the USA government.

The European Medicines Agency is now reviewing Epidiolex for treating seizures associated with LGS and Dravet Syndrome, with a decision on whether or not to recommend approval expected early next year. But then Hendershot learned about a trial of Epidiolex at New York University.

The oral solution contains cannabidiol, or CBD, a nonpsychoactive compound that has proved beneficial in reducing the catastrophic, potentially life-threatening seizures that accompany both conditions.

The FDA has previously approved synthetic medications that resemble or are identical to THC.

Based on the potential for abuse, the Drug Enforcement Administration (DEA) categorizes chemicals into five schedules, with Schedule 1 substances - like marijuana and heroin - considered the most deadly, and deemed to have no medical benefit whatsoever.

The agency, he added, remains concerned about "the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims". But experts have said that having a regulated medication with standard dosing and supply is crucial for patient safety, a sentiment echoed by Gottlieb in his statement Monday. Others said they are anxious to try an FDA-approved product. "But it's also important to note that this is not an approval of marijuana or all of its components". GW Pharmaceuticals has monitored Epidiolex' effects on over 500 children and adults who are afflicted with seizure conditions that are hard to treat using traditional medications for epilepsy.

In 2013, the FDA gave GW Pharmaceuticals of the United Kingdom permission to use the cannabidiol-derived drug, in clinical trials. Moreover, this is a purified form of CBD. Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug's uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. "This is how sound medical science is advanced".



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