First Marijuana Based Medicine Finally Given Thumb’s Up From FDA

First Marijuana Based Medicine Finally Given Thumb’s Up From FDA

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Marijuana has finally been acknowledged for its medicinal value. The medicine, approved by the Food and Drug Administration (F.D.A.), is called Epidiolex. It treats two rare forms of crippling seizure disorders.

Marijuana is still a Schedule I narcotic

And this medicine compels the FDA to reclassify the plant. Stat News reports on the historic decision:

The drug, GW Pharmaceuticals’ Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.

“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,” FDA Commissioner Scott Gottlieb said in a statement. “And, the FDA is committed to this kind of careful scientific research and drug development.”

Regulating medical marijuana makes sense. Administering effective seizure relief to a small child should be supervised by a physician.

Hopefully, this will open the door on a federal level to reexamine the health benefits of marijuana.

What is Epidiolex and why is this groundbreaking?

A GW pharmaceutical’s representative broke down the benefits of Epidiolex:

“This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine,” GW CEO Justin Gover said in a statement. “These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

A company representative said the list price for the medication had not been set yet.

Patients with Lennox-Gastaut and Dravet syndromes, which typically emerge in the first few years of life, can suffer from debilitating and recurrent seizures, sometimes dozens a day. One in five patients is estimated to die before they are 20 years old.

The FDA has previously approved synthetic marijuana, but this is the first FDA approved medicine that is actually made of the marijuana plant. It is still classified as either a Schedule II or Schedule III drug.

Stat reports:

The FDA has previously approved synthetic medications that resemble or are identical to THC. The drugs are listed as Schedule II and Schedule III, meaning they have medicinal value but also potential for abuse.

Perhaps the profit motive of pharmaceutical companies will finally merge with the now proven medical benefits of marijuana.

 

Featured Image: Pixabay CC Rexmedlen