The new drug will be used to treat severe epilepsy in both children and adults.
June 25th, 2018 marks an historical day in American prescription-drug history. It’s the first time the U.S Food and Drug Administration (FDA) has approved a drug for use in America that’s drawn from the marijuana plant.
The FDA has approved the use of a purified form of the drug cannabidiol (CBD), something that forms one of more than 80 active chemicals in marijuana. The product has been undergoing numerous tests, to get to this point. So far, it’s been approved to treat seizures in people two years of age and older who suffer from two rare, severe forms of epilepsy.
Of course, the Administration has been quick to note that this step only approves a portion of the marijuana plant for medical purposes. It doesn’t present an overall approval of marijuana in general, or all of its components.
The Administration states on its website that the medicine is being delivered to patients in “a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits.” Sounds like a win.
Is further research being done by the FDA to derive additional medical drugs from the marijuana plant? Yes. According to information found on the FDA’s website, research is currently in the works.
Interestingly, the process involves a number of federal agencies in addition to the FDA, including the National Institute on Drug Abuse, part of the National Institutes of Health, and the Drug Enforcement Administration.
The FDA also has an active program to assist drug developers who want to investigate marijuana or its components through properly controlled clinical trials. These can be used to demonstrate the potential for safe and effective uses of products derived from the plant.
The times they are a changin’. For more on this groundbreaking approval, click here.