FDA approves first medicine made from marijuana in US

Help without High

On Monday the US Food and Drug Administration (FDA) approved the country’s first medication derived from marijuana. GW Pharmaceuticals’ Epidiolex, is a drug administered as an oil to treat two kinds of epilepsy, Dravet or Lennox-Gastaut syndromes.

As reported by Andrew Joseph in STAT, the medication is made of cannabidiol, or CBD, “a component of marijuana that does not give users a high.” Administered as an oil, it reduced the number of seizures by about 40 percent in clinical trials.

Lennox-Gastaut and Dravet syndromes usually begin very early in life and cause debilitating and recurrent seizures. By age 20, one in five patients will die.

According to FDA Commissioner Scott Gottlieb, “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. The FDA is committed to this kind of careful scientific research and drug development.”

While FDA officials had acknowledged that they supported the approval of Epidiolex, and an advisory panel had unanimously recommended that action, some people were concerned about its effects on the liver. Experts have stated that this risk could be handled by doctors who monitor their patients during treatment. Still, the Drug Enforcement Administration (DEA) will have to reclassify CBD before GW can market Epidiolex. Because it comes from marijuana, it is considered a Schedule I drug, one with “no medical value and a high risk of abuse.” The DEA is expected to make that change within 90 days. The list price for the medication has not been established.

In the words of GW CEO Justin Gover, “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. 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.”

While six other drugs have been approved to treat seizures caused by Lennox-Gastaut, but none have been approved for Dravet. Epidiolex was approved for just the two conditions, but doctors may decide to prescribe it “off label” for other epileptic diseases. The medication is derived from a proprietary strain of cannabis that has high levels of CBD and low levels of THC, the part that makes people high. Previously, the FDA approved synthetic medications that resemble or are identical to THC. They are designated as Schedule II and Schedule III, indicating that they have medicinal value but also potential for abuse.

Moving to states where marijuana is legal has been the only option for parents whose children have the conditions, but having a regulated medicine is important for patient safety, according to the FDA. Gottlieb also described the lengthy clinical development of Epidiolex as a model for bringing products made from marijuana to the market and said that the FDA is eager to help companies to pursue research programs involving marijuana as long as their products are safe and effective, as proven by clinical trials.