FDA approves first marijuana-based drug

The Food and Drug Administration approved a seizure medication made from marijuana on Monday, the first drug of its kind in the U.S.

The drug is made from purified cannabidiol, or CBD, a compound found in the cannabis plant. MOst CBD comes from hemp, and for any plant to be considered "hemp" it must contain less than 0.03 percent THC.

Most patients with LGS and DS require multiple seizure medications and the majority are resistant to now approved anti-epileptic drugs.

"This approval serves as a reminder that sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies", Gottlieb told reporters.

Aside from Epidiolex, GW Pharma also sells Sativex-which includes components of marijuana-in 30 countries as a treatment for multiple sclerosis-related spasticity.

"The promotion and use of these unapproved products may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases", Gottlieb said. "If the FDA makes it clear that a cannabis-based pharmaceutical drug has medicinal value, then Congress can no longer claim there is no medicinal quality for cannabis".

Epidiolex's effectiveness was studied in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, comparing Epidiolex to a placebo.

Federal agencies have 90 days to determine the scheduling of Epidiolex.

Fox hailed Monday's FDA action as a win for the broader medical marijuana community, in that it will facilitate more clinical research into the drug's medical benefits.

Research has shown that CBD has the potential to treat seizure conditions, like Dravet syndrome. 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).

"Children with Dravet syndrome typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others", said the FDA.

The FDA's green light on Epidiolex, coupled with the DEA's reclassification of CBD, could have big implications for the future of cannabis-based medicine.

"I preferred this to some of those other options because it's is a commercial product that has gone through rigorous testing", said Hendershot, who lives in Rochester, New York.

A new epilepsy medicine derived from cannabis could be in the hands of patients before any medical marijuana reaches the shelves in Ohio.

Ironically, an advisory panel for the FDA unanimously approved the recommendation for Epidiolex one day before 4/20.

In 2013, the FDA gave GW Pharmaceuticals of the United Kingdom permission to use the cannabidiol-derived drug, in clinical trials.

"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.

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

  • Santos West