Epidiolex, the first cannabis-based drug to be approved by the Food and Drug Administration (FDA), has been rescheduled by the Drug Enforcement Administration (DEA) and now looks set to hit the market in weeks.
GW Pharmaceuticals announced that its cannabis-based oral solution has been down-classified to Schedule V controlled substance by the drug control agency. The UK-based biopharmaceutical company made the announcement in late September alongside its U.S. subsidiary Greenwich Biosciences.
This classification is the lowest restriction level. It includes substances that are known to offer proven medical benefits and are less likely to be abused. Examples of such include codeine-containing cough medications and anti-epilepsy medicines, such as lacosamide (VIMPAT).
The FDA approved Epidiolex back in June for treatment of seizures due to Dravet Syndrome or Lennox-Gastaut Syndrome, two rare forms of childhood epilepsy that can be hard to control.
The drug, which contains the cannabis constituent cannabidiol (CBD) but not the high-producing tetrahydrocannabinol (THC), is indicated for patients who are two years or older.
However, the DEA had to take some time before rescheduling Epidiolex. This was mainly because marijuana is classified as a Schedule I drug, which means it is a substance with high potential for abuse and currently has no accepted medical use. The effect of this is that CBD, and by implication, Epidiolex may be deemed a Schedule I substance, making its use illegal.
The reclassification as a Schedule V substance effectively clears the way for the drug to hit the market. GW Pharmaceuticals has already revealed plans to make it available in the market within a few weeks.
“With this final step in the regulatory process completed, we are working hard to make EPIDIOLEX available within the next six weeks as we know there is excitement for a standardized version of cannabidiol that has undergone the rigor of controlled clinical trials and been approved by the FDA,” GW CEO Justin Gover said.
The popularity of CBD has continued to rise, with a variety of benefits attributed to it. The compound is available in different forms, with the most popular being oils.
However, the reclassification by the DEA does not apply to CBD in general. It applies only to CBD products with THC content not exceeding 0.1 percent and approved by the FDA.
Other CBD products that contain more than 0.1 percent THC or lack FDA approval remain Schedule I substances and are, therefore, illegal.
“We see our business distinct from Tilray and other companies that are seeking to be active in the broader cannabis space,” Gover told CNBC’s “Power Lunch,” noting that the reclassification suggested that regulatory authorities are ready to approve the use of cannabis for medical purposes if backed by sound scientific research.
CBD oils and lotions are mostly regarded as illegal under federal law. But the DEA does not take action against individuals using them, according to an agency spokesman interviewed by CNBC.
There is also a lack of agreement between federal and state laws on the subject. Marijuana products, including CBD, can be legally obtained in some states.
It is reported that the DEA will be more likely to enforce the prohibition laws if bigger consumer product companies were to start selling CBD oils.
The FDA had made it clear when announcing the approval of Epidiolex a few months ago that the action did not apply broadly to CBD. It noted that the medicine contained a purified form of the compound, suggesting this contributed to the decision to approve it.