Published: Tue, June 26, 2018
Medicine | By Earnest Bishop

FDA Approves First Drug Derived From Marijuana Plant

FDA Approves First Drug Derived From Marijuana Plant

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

The FDA news signals that the DEA will likely adjust its scheduling for CBD, which is now a Schedule I substance, denoting high potential for abuse and no medical applications.

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it.

He added, "This is how sound medical science is advanced".

"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. Scott Gottlieb stressed in a statement that approval of the drug wasn't a co-sign for marijuana, but just for "one specific CBD medication for a specific use".

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. "And, the FDA is committed to this kind of careful scientific research and drug development", Dr. Gottlieb said.

The FDA has previously approved synthetic versions of another cannabis ingredient for medical use, including severe weight loss in patients with HIV. On the other hand, CBD derived from cannabis is a schedule I drug, and only 28 states and Washington, DC have so far legalized it; 15 states have only legalized CBD by itself.

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That's because these kids did not experience as many side effects from the cannabidiol, which can include tiredness, decreased appetite, diarrhea and signs of possible liver damage, Devinsky explained.

Since receiving Epidiolex, Hendershot says her daughter has been able to concentrate more and has had fewer "drop" seizures - in which her entire body goes limp and collapses. As well, CBD remains in a legal grey area, making it hard for patients outside of legal states to acquire.

While there was initially some confusion about whether the Drug Enforcement Administration might block the sale of Epidiolex, given cannabis' status as a Schedule I substance, Epidiolex manufacturer GW Pharmaceuticals doesn't believe that will be the case. "Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases".

A reclassification is expected within 90 days, according GW Pharmaceuticals.

The FDA is not required to follow the advisory panel's advice but usually does. A prescription drug provides a workaround to this issue.

Medical marijuana is available in about half of the states. One in five patients is estimated to die before they are 20 years old. Others said they are anxious to try an FDA-approved product.

Prior to the FDA decision, a press officer for the DEA confirmed to Leafly that the FDA decision will prompt action from the DEA.

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