The Food and Drug Administration has approved the first-ever cannabis-based prescription medication. The oral drug Epidiolex is intended for patients to treat two rare, and severe forms of epilepsy—Lennox-Gastaut syndrome and Dravet syndrome.
Epidiolex contains cannabidiol, one of the chemicals found in marijuana, however, it will not produce a high that is commonly seen in THC. FDA commissioner Dr. Scott Gottlieb stressed in a statement that approval of the drug wasn’t a co-sign for marijuana, but just for "one specific CBD medication for a specific use." It also marks a landmark moment in the agency’s advancement in considering cannabis for medical purposes.
"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. And, the FDA is committed to this kind of careful scientific research and drug development," Dr. Gottlieb said. "Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients."
Ironically, an advisory panel for the FDA unanimously approved the recommendation for Epidiolex one day before 4/20. Agency officials paved the way for the cannabis-based drug by defending its effects in a briefing document, writing, "In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders." Any drug containing cannabis from here on out will still need to clear plenty of hurdles before getting approval. Still, it appears that the agency is heading in the right direction when it comes to keeping an open mind when considering possible alternative approaches to medicine.
