First Marijuana Drug Gets Approved By The FDA
The United States Food and Drug Administration has approved the country's first marijuana-based prescription medicine Epidiolex on Monday, June 25.
FDA Approves Epidiolex
Epidiolex is reportedly an oral solution meant to treat seizures that are known to be associated with two particular types of epilepsy, the Lennox-Gastaut syndrome, and Dravet syndrome, for children 2 years old and above. It's the first-ever FDA-approved drug treatment for the Dravet syndrome.
Both Lennox-Gastaut syndrome and Dravet syndrome arise in childhood, often leading to development problems.
"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," FDA Commissioner Scott Gottlieb, M.D. says in a statement, underlining the agency's commitment to rigorous "scientific research and drug development."
Gottlieb stresses that clinical trials that are careful and being controlled, combined with the FDA's strict process of drug approval as the best way to deliver marijuana treatments to the public. This way, patients can be assured of the drug's effectivity.
While FDA is prepared to continue supporting scientific research focusing on marijuana-based products with medicinal uses, they will also be monitoring the market for CBD-related products making medical claims that are unproven.
CBD is the chemical component of marijuana. It's not responsible for marijuana's intoxication effects. Rather, it is tetrahydrocannabinol that accounts for these effects.
"In addition to another important treatment option for Lennox-Gastaut patients, this first-ever approval of a drug specifically for Dravet patients will provide a significant and needed improvement in the therapeutic approach to caring for people with this condition," Billy Dunn, M.D., director of FDA's Division of Neurology Products, explains.
Epidiolex Side Effects
During clinical trials, the researchers were able to observe the following effects: sleepiness, sedation, lethargy, fatigue, elevated liver enzymes, decreased appetite, diarrhea, rash, malaise, weakness, insomnia, poor quality sleep, and various infections.
There are also potential risks with taking the medicine. Epidiolex's risks are in line with those of other epilepsy treatment drugs. These include suicidal thoughts, suicide attempts, agitation, aggression, depression, and also panic attacks.
Another Decision In The Books
This one landmark approval could have another one following it soon: the reclassification of CBD by the United States Drug Enforcement Administration.
Currently, CBD is classified as a Schedule I drug, which are substances with a high potential for abuse and no accepted medicinal use. Others in this classification are heroin and LSD. The drugs in this classification are strictly regulated and illegal in federal law.
Until the DEA decides to reclassify CBD, the company behind Epidiolex, GW Pharmaceuticals, can't market Epidiolex. FDA has determined that CBD has negligible abuse potential.