GW Pharmaceuticals announced Thursday that its cannabis-based medication for two severe forms of epilepsy, Epidiolex, will be available on the market within the next six weeks. The pharmaceutical drug will be the first medication made up of cannabis that can be legally prescribed across the country.
The announcement follows the Drug Enforcement Administration’s (DEA) decision to give the treatment a Schedule V classification, the lowest classification for controlled substances. This category marks the drug as a chemical with low abuse potential and medicinal properties. Epidiolex is made up of CBD with less than 0.1 percent of THC.
“We are pleased that the DEA has placed Epidiolex in the lowest restriction Schedule, because it will help ensure that patients with LGS and Dravet syndrome, two of the most debilitating forms of epilepsy, can access this important new treatment option through their physicians,” said GW Chief Executive Officer Justin Gover in a statement.
Epidiolex was approved by the FDA in June, which forced the hand of the DEA to changing its stance on marijuana’s current scheduling. The drug is intended for use by patients two years of age and older with these rare forms of epilepsy that tend to become apparent during childhood and are often more difficult to treat than other forms of epilepsy.
Researchers were expecting that the FDA would reschedule CBD all together, according to Business Insider. Instead, they rescheduled only FDA-approved medicine containing the compound. Currently, this only includes Epidiolex. CBD remains a schedule I substance, meaning it has no accepted medical use and a high potential for abuse.
“What’s different with this drug is that this is a well-studied and well-controlled product,” Laura Lubbers, chief scientific officer of a nonprofit called Cure told Business Insider in April.
“We see our business distinct from Tilray and other companies that are seeking to be active in the broader cannabis space,” Gover said in an interview Thursday with CNBC’s “Power Lunch.” “That’s a different business. It’s not one that we’re involved with, but what I would say is this is yet another validation that if you apply the rigors of science and law to cannabis research, that the regulatory authorities, namely the FDA and DEA, will act and respond to the need of patients to make these kind of medications available.”
Igor Grant, M.D., director for the University of California at San Diego for Medicinal Cannabis Research says that the DEA’s decision is a “step in the right direction,” and that “it’s good for the public that “the agency acknowledges the medical science behind CBD as a useful medicine and it’s not particularly dangerous.”