FDA approves its first marijuana-derived drug

FDA approves its first marijuana-derived drug

"Compared to other drugs used to treat epilepsy, I think Epidiolex, which is 99-percent pure cannabidiol, has a better side-effect profile than numerous available drugs", Devinsky said. Under the Controlled Substances Act, marijuana is a Schedule I drug, meaning it has a high potential for abuse and no recognized medical objective (heroin, LSD, and ecstasy are also Schedule I drugs).

"In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD", Devinsky said.

The FDA cites a number of side effects associated with Epidiolex that may give some patients pause, however, including the potential for increased liver enzymes, weakness, poor sleep quality, and diarrhea, among others. Epidiolex, produced by GW Research Ltd., is now approved to treat the conditions known as Lennox-Gastaut syndrome and Dravet syndrome.

In the meantime, it is possible that once on the market, Epidiolex could be prescribed for conditions other than the ones it's approved for.

The drug contains nearly non of the psychoactive chemical from marijuana that makes people high and proved through testing to be effective in treatment of certain pediatric seizure patients.

"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies". Epidiolex contains CBD, a cannabis chemical compound skyrocketing in popularity and driving what is estimated to have doubled into a $200 million market in 2018.

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

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With the historic approval, the London-based company behind the drug, GW Pharmaceuticals plc, is expecting another consequential decision in the coming weeks: getting the US Drug Enforcement Administration to reclassify CBD.

The FDA is not required to follow the advisory panel's advice but usually does.

That's according to Steve Fox, the director of VS Strategies, which was retained by GW Pharmaceuticals to assist with lobbying and public relations efforts. "This new treatment provides new options for patients". This status has stifled rigorous research, because the federal government will not pay for it.

"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", Gottlieb said.

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

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. Carreno says that once the drug is descheduled, CBD manufacturers must register with the DEA-and that will make all the difference to the industry in the U.S.

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