U.S. approves first marijuana-based medicine

U.S. approves first marijuana-based medicine

While Monday's approval makes Epidiolex the first cannabinoid-based prescription medicine approved in the United States, drugs with a synthetic version of molecules derived from marijuana have been approved.

The drug is derived from the cannabidiol of cannabis, and, as the plant is yet to be decriminalized by federal regulators, its approval gives GW Pharma a lead among cannabis-exposed companies in the US financial markets. But some parents worry it could hurt Colorado's cannabidiol (CBD) industry already helping children who are suffering from seizures. Where is weed legal? Almost all patients with these conditions continue to have daily seizures-some having multiple per day-despite the use of legally available drugs.

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 drug, administered as an oil, could significantly improve the quality of life for patients with two types of childhood epilepsy: Dravet syndrome, a genetic illness that kills up to 20 percent of sufferers before age 20, and Lennox-Gastaut syndrome, a form that begins between ages 3 and 5 and causes intellectual disability.

"This is an important medical advance", Gottlieb said. Carreno says that a leader drug like Epidiolex often paves the way for other less expensive-and untested-CBD products.

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The FDA notes that it will still "take action" against illegal CBD products making "serious, unproven medical claims". While CBD has purely medicinal purposes, the other compound, tetrahydrocannabinol (THC), is what gives marijuana users the psychoactive effects commonly associated with the plant. Scott Gottlieb stressed in a statement that approval of the drug wasn't a co-sign for marijuana, but just for "one specific CBD medication for a specific use". The FDA has previously sent warning letters to companies that hyped their products as cancer or Alzheimer's fighters.

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

Epidiolex is created to treat two rare forms of childhood epilepsy. Accordingly, before Epidiolex is ready for use amongst patients, it needs to be appropriately reclassified - something GW Pharmaceuticals expects to see happen within the next three months.

Although several states have legalized the medical and recreational use of marijuana, the federal agency had yet to do so until today. "We want the whole-plant extracts that our kids are using and that have worked for them for years".

Commenting on the agency's decision, NORML Deputy Director Paul Armentano said: "The FDA's approval of this plant-derived medicine provides an additional option to patients seeking the therapeutic benefits of cannabis". European approval is expected in early 2019.

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