For the first time, the U.S. government Monday approved a drug with ingredients derived from marijuana, paving the way for research into similar products.
The Food and Drug Administration said Epidiolex, which treats seizures from rare types of epilepsy, contains a chemical from marijuana known as cannabidiol, though it won’t produce the “high” associated with the common street drug.
The intoxication linked to marijuana comes primarily from a chemical known as “THC.”
The FDA said British drugmaker GW Pharmaceuticals conducted studies to verify their product wouldn’t result in abuse, since marijuana itself is a scheduled drug with a potential for abuse under federal law.
“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,” said FDA Commissioner Scott Gottlieb.
“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,” he said. “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.”
GW Pharmaceuticals studied the drug — dispensed in the form of a strawberry-flavored syrup — in more than 500 epileptic children and adults with hard-to-treat seizures, and the drug reduced seizures when combined with older epilepsy drugs.
The FDA has approved for medical use dronabinol, a synthetic version of THC, for appetite loss in cancer and AIDS patients.
Dr. Gottlieb said interest in the development of marijuana-related therapies has been growing over the past decade, and that drugmakers interested in the field will find a “robust clinical development program” at his agency.
However, he said the FDA will subject these products to careful, science-based reviews and watch out for the illegal marketing of unapproved products with cannabidiol, or “CBD.” Epidiolex is an oral solution that consists of plant-derived CBD.
It will be used by patients with Lennox-Gastaut and Dravet syndromes, which can develop in childhood and often result in seizures and developmental problems, such as poor motor skills.
The drug is the first one approved for Dravet, so it was granted a fast-track review by the FDA.
GW Pharmaceuticals hailed the approval as “a historic milestone” that caps years of hard work with patients, families and their doctors.
“These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care,” said company CEO Justin Gover.
Doctors also said they appreciate being able to get a consistent product, subject to the usual government safety and purity regulations.
“I’m really happy we have a product that will be much cleaner and one that I know what it is,” Dr. Elaine Wirrell, director of the Mayo Clinic’s program for childhood epilepsy, told The Associated Press. “In the artisanal products there’s often a huge variation in doses from bottle to bottle depending on where you get it.”