In the context of an ever-louder international debate on whether patients with severe forms of epilepsy should be allowed to use medical cannabis to manage their condition, the Food and Drug Administration have just officially approved one such drug.
Recently, international media have bombarded their audiences with coverage of the case of a British mother whose medical cannabis store was seized by United Kingdom customs.
The woman was carrying cannabis oil that she was bringing to the U.K. to help manage the condition of her 12-year-old son, who has a severe form of epilepsy.
The dispute eventually led U.K. officials to make an exception for the young boy and return the confiscated substance.
In the United States, cannabis has been legalized for medical use in some states, but until recently, it had yet to gain Food and Drug Administration (FDA) approval, as safe in the treatment or management of any given medical condition.
But on Monday, the FDA finally approved the use of an oral cannabidiol (CBD) solution called Epidiolex for the treatment of two rare forms of epilepsy — Lennox–Gastaut syndrome and Dravet syndrome — in patients aged 2 and older.
Though CBD is derived from the marjiuana plant Cannabis sativa, it does not induce a state of intoxication. The “high” is instead caused by another cannabis component called tetrahydrocannabinol (THC).
“The FDA [have] been supportive of research in this area for many years,” notes FDA Commissioner Dr. Scott Gottlieb in an official statement. “But marijuana is a Schedule I compound with known risks.”
The Drug Enforcement Administration (DEA) claim that Schedule I substances “are defined as drugs with no currently accepted medical use and a high potential for abuse.”
For this reason, Dr. Gottlieb specifies that the FDA needed to see solid evidence, meeting rigorous criteria, before approving any cannabis-derived drug for medical therapy. And Epidiolex is the first drug to have achieved these high standards.
“This is an important medical advance. But it’s also important to note that this is not an approval of marijuana or all of its components,” the Commissioner stresses.
“This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition,” he adds.