Cannabis Medicine To Treat Epilepsy Officially Approved By FDA

FDA approves first ever drug derived from marijuana | TheHill

FDA approves first ever drug derived from marijuana | TheHill

A new epilepsy medicine derived from cannabis could be in the hands of patients before any medical marijuana reaches the shelves in Ohio. Others said they are anxious to try an FDA-approved product.

For medical marijuana advocates, it's a clear vindication of a fundamental premise of a decadeslong movement: that cannabis can have legitimate medical applications and it isn't the bogeyman that the federal government has long made it out to be.

The new medication enters an increasingly complicated legal environment for marijuana.

"It makes it harder for Congress to continue to list cannabis as a Schedule I controlled substance", Debra Borchardt, CEO at cannabis-focused financial media outlet Green Market Report, told Benzinga in April.

Gottlieb noted that the action was "not an approval of marijuana or all of its components" but rather of one specific CBD medication for a particular use. They're not regulated the way pharmaceutical drugs are, so the consistency and dose can vary widely. In fact, research is limited to studying the addictive behavior of cannabis or the negative impacts of the drug. Last year, Azadian became the first marijuana startup to join the Johnson & Johnson JLabs Innovation network, an ecosystem created to give budding companies access to the resources and leadership they need to get off the ground. Supporters of the FDA's Epidiolex approval mark it as a major medical milestone, and are hopeful that this will open the doors to further research of cannabis as a medical cure for other ailments. Reportedly, this cannabis based medicine is formulated to treat epilepsy in children and is claimed to be the first of its kind to get merchandized in the USA pharmaceutical market.

GW Research Ltd., the London-based company who produced Epidiolex is also expecting another decision that will require reclassifying CBD and allowing other marijuana-derived medications as well as reducing limitations on marijuana-related research. This must occur before the drug can be sold in the U.S. Demand for CBD is at an all-time high.


CBD oil is now sold online and in specialty shops across the US, though its legal status remains murky. The medicine is then formulated in a way that makes a consistent product. The FDA has been warning the public against falling for these unproven claims.

Gottlieb added that controlled clinical studies evaluating a drug's safety and efficacy in combination with a careful review through the FDA's drug approval process, is the most suitable way to introduce marijuana-based treatments to patients.

There are side effects, the most common being sleepiness, Gover said. "Cannabis" is a general term referring to all plants in the Cannabis sativa family. CBD does not produce strong psychoactive effects and it was well-documented to reduce the number of seizures by about 40 percent. CBD from imported hemp is not.

A flowering marijuana plant.

Medical marijuana is available in about half of the states.

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