Wednesday, April 25, 2018

First FDA-Approved Drug Derived from Marijuana

An FDA advisory committee has recommended the approval of a new drug, called Epidiolex, for the treatment of several types of epilepsy in children . If the FDA accepts the recommendation, Epidiolex will be the first FDA-approved drug to contain cannabidiol (CBD), a non-psychoactive substance purified from marijuana (cannabis).

Following the discovery that CBD had certain medical benefits, a number of states (30 at last count) legalized marijuana for certain medical purposes. Several other states legalized just the CDB extract. Relatively pure CBD is now widely sold over the internet for a host of medical and quasi-medical conditions, including as a sleep aid, an anti-anxiety treatment, an anxiety reliever, and even as a cure for certain types of cancer. But while some of these alleged benefits of CBD may be true, none has been proven by rigorous scientific studies. In addition, the purity and consistency of non-FDA-approved drugs sold over the internet can be suspect.

What makes Epidiolex different is that its developer and manufacturer has gone through the necessary testing to prove its medical efficacy. As a result, Epidiolex is poised to receive FDA approval for the treatment of two rare types of epileptic seizures. A distinct advantage of FDA approval is that patients with the forms of epilepsy targeted by the drug can be assured of the drug's purity and consistency of dose from one prescription to the next, because the drug will be produced according to best pharmaceutical practices.

With further testing, the FDA could expand the approved use of CBD to include other medical conditions. In the meantime (even if the FDA does eventually approve CBD, or even marijuana, for other uses), I doubt that marijuana-users will give up their favorite form of self-medication.

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