First Marijuana-Based Drug Approved by FDA

In a press release the Food and Drug Administration (FDA), announced that Epidiolex, a cannabis-based oil, cannabidiol, (CBD) was approved. The solution, which is taken orally, can be used to treat primarily two rare forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

According to the release, the CBD in a cannabis plant cannot cause the psychological effects that tetrahydrocannabinol (THC) can.

The FDA also released a statement from its commissioner Scott Gottlieb, on the FDA’s stance on marijuana-based treatments, making assurances that the FDA is open to these treatments so long as they continue to go through the FDA’s “well-controlled clinical studies.”

The two syndromes had previously lacked treatments, and both are considered diseases that can make daily life a struggle. The CBD oil can reduce the frequency of seizures among those tested significantly. A patient “Medication Guide” will accompany Epidiolex, which will list out essential information about the drug such as side effects.

CBD has been a growing market, with people using the oil for the effects without the “high.” For some, the drug relieves stress, anxiety, and minor aches and pains. For now, the substance is only available in states where medical or recreational marijuana is legal. Dr. Esther Blessing, a psychiatrist and researcher at New York University, in a statement to NPR, noted that “there’s good evidence to suggest that CBD could be an effective treatment of anxiety and addiction.”

A study in 2011 showed that CBD could significantly reduce anxiety after a controlled test involved participants taking either the drug or a placebo before speaking in front of a large audience.

The drug is also being tested to see if it will reduce other disorders such as Post Traumatic Stress Disorder and addictions and cravings to more severe drugs such as opioids or alcoholism.

While the oil had been used previously to help prevent seizures, without the testing and regulation from the FDA, it was difficult to get a consistent product because the contents could vary.

CBD remains listed as a schedule 1 substance which makes it a federal crime to possess under the Drug Enforcement Administration (DEA) and the Controlled Substances Act (CSA); however, the FDA conducted studies to “assess the abuse potential of CBD.” The FDA is also going to provide “recommendations” to the DEA concerning controlling the drug.

The DEA is expected to make a decision sometime soon about whether or not it will reclassify the drug and what implications that may have for marijuana in general or in other forms for medical purposes. In a statement with The Verge, DEA spokesman Melvin Patterson noted that “the FDA’s findings on something like Epidiolex will weigh heavily on the decision-making process.” While a schedule for this reclassification is unclear, lighter DEA regulation on CBD is promising, especially since the FDA is reporting that the DEA is currently working on reclassification.

Currently, schedule 1 drugs cannot be prescribed by a doctor until the DEA’s stance has officially changed. In states where the drug has been legalized, doctors can prescribe the substance and patients can use their insurance to cover the costs. Colorado, in particular, passed a law to streamline the process to allow this, regardless of federal law, by September, where other states may not have the same provisions and may have to wait to allow prescriptions of the drug.

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