FDA Approves Cannabis-Derived Medicine for the First Time

FDA Approves Cannabis-Derived Medicine for the First Time

The FDA has approved the U.S's first marijuana-based medicine. Under the Controlled Substances Act, marijuana is a Schedule I drug, meaning it has a high potential for abuse and no recognized medical goal (heroin, LSD, and ecstasy are also Schedule I drugs). In some cases, patients have moved to states that have legalized medical marijuana in order to have access to the drug. "Nonetheless, these alternatives should not be regulated as options to replace the use and regulation of herbal cannabis - a product that humans have used safely and effectively as a medicine for thousands of years and is approved today by statute in 30 states".

And Epidiolex's approval doesn't mean other CBD substances are OK to sell, Gottlieb said.

It's an option for those patients who have not responded to other treatments to control seizures. The companies behind those products say the CBD is extracted from hemp, which contains little THC, and is allowed under the federal farm bill. And Epidiolex could well be the first in a wave of marijuana-based therapies; agency officials said they have implemented regulatory processes to help drug developers test marijuana or its components in their own clinical trials.

The FDA previously issued warnings to CBD producers that claimed their products could treat specific diseases, such as cancer or Alzheimer's.

Epidiolex was recommended for approval by an advisory committee in April, and the agency had until this week to make a decision.

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The drug should provide a more reliable alternative than the homemade cannabis oil parents for years have made for the children, said Devinsky, who once treated Vivian Wilson of Scotch Plains, a toddler with Dravet syndrome. 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. "So we don't really know much about the effect of CBD on the developing brain or whether it could be addictive in the long run".

The medication, which will continue to be manufactured in Britain, will be marketed by Greenwich Biosciences, the US subsidiary of GW Pharmaceuticals. Previous year a government-commissioned group concluded that the lack of scientific information about marijuana and CBD poses a risk to public health.

GW Pharmaceuticals said it expected to make the product available by the fall, pending expected action by the Drug Enforcement Administration to reclassify the drug.

The drug is called Epidiolex and is a plant-derived oral solution of cannabidiol (CBD)-a chemical component of marijuana that does not cause intoxication or a euphoric "high". The agency is expected to do so within 90 days. More importantly, a DEA representative recently affirmed that outlook, telling Leafly reporter Ben Adlin that if Epidiolex is approved, the DEA will "absolutely" reschedule CBD. And the company plans to continue importing the medicine, bypassing onerous USA regulations on manufacturing restricted substances.

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

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