FDA approves first marijuana-based epilepsy medication

This drug is a treatment option of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

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".

It's not clear how quickly the drug will be available for prescription. In contrast to THC, the far more popular cannabinoid CBD does not produce strong psychoactive effects when consumed.

The FDA still hasn't given its blanket approval to marijuana as a "safe and effective drug", though it has OK'd three medications that contain synthetic compounds similar to those found in the marijuana plant.

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

The U.S. health regulator approved GW Pharmaceuticals Plc's epilepsy treatment on Monday, making it the first cannabis-based drug to win approval in the country and opening floodgates for more research into the medicinal properties of cannabis.

A new epilepsy medicine derived from cannabis could be in the hands of patients before any medical marijuana reaches the shelves in Ohio. Some LGS patients have to wear helmets to avoid brain injuries from "drop seizures", where muscles suddenly become limp and cause standing patients to collapse. He would not give any information on cost, saying only that it will be discussed with insurance companies and announced later.

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FDA said it is providing medical and scientific information and recommendations to the DEA about CBD. The chemical's use in seizure prevention is well-documented in reputable research, and now, after conducting its own trials, the FDA is on board. Those taking 20 mg of Epidiolex a day had 42 percent fewer seizures, on average, compared with 37 percent fewer seizures in the group taking 10 mg of the drug, and a 17 percent reduction in the placebo group.

"I'm really happy we have a product that will be much cleaner and one that I know what it is", said Dr. Ellaine Wirrell, director of the Mayo Clinic's program for childhood epilepsy.

"I don't know a mom or dad in their right mind who is going to change what's already working", said Heather Jackson, CEO of Realm of Caring, a charitable group affiliated with Colorado-based CW Hemp, one of nation's largest CBD companies.

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.

Marijuana now has an accepted medical use.

The day-to-day impact of these conditions is significant with high rates of early mortality, the company said. This is called off-label use and is a common practice with many medications.

Many parents already are giving children unregulated CBD formulations that are available in medical marijuana dispensaries in the many states where such operations are legal.

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