FDA Approves First CBD Prescription Drug

In June 2018, the US Food and Drug Administration approved the first prescription drug made from marijuana.  The active ingredient in the medication is CBD, it’s manufactured by GW Pharmaceuticals and it has been approved to treat two rare forms of childhood epilepsy.  The approval is for children aged 2 and older.

“The results from these studies provide substantial evidence of the effectiveness of CBD” the FDA said in briefing documents.

“CBD represents hope for the many individuals living with intractable seizures and rare epilepsies, who every day face incredible challenges and disabling seizures, and live with the continual risk of serious injury and death,” said Philip Gattone, president and CEO of the Epilepsy Foundation.

Like REMEDY_ASSIST. this products is different from medical marijuana, because it does not contain THC, the compound that gets you high.  The active ingredient is cannabidiol (CBD), which is derived from cannabis plants, and purified to 99 percent.

The ruling is a milestone on several fronts:

  • It validates that CBD has therapeutic benefits
  • Given that CBD is approved for use in children as young as 2, it validates that CBD is safe
  • The medical profession will start to recommend CBD for epilepsy and a range of other health issues like autism, anxiety, pain, inflammatory and autoimmune disorders.
  • It will spur more research into CBD
  • The US Drug Enforcement Administration will need to reclassify CBD. Currently, CBD is classified as a Schedule I drug by the DEA. Schedule I drugs include heroin and LSD as well as marijuana. They’re defined as substances with high abuse potential and “no currently accepted medical use.” As such, Schedule I drugs are strictly regulated, and use of them—including medical use—is against federal law.