In a landmark moment for medical cannabis advocates across the country, the FDA-approval of marijuana-sourced epilepsy drug Epidiolex has declassified CBD as a schedule 1 substance and is likely to open the floodgates for medical marijuana developments across the country.
The new drug Epidiolex was developed to treat two rare forms of epilepsy by British pharmaceutical company GW Pharmaceuticals.
The drug contains the non-psychoactive compound CBD (aka cannabidiol) found in cannabis and will now be available with a doctor’s prescription and may be included under medical insurance plans.
Before Epidiolex was approved by the FDA on June 25th, CBD was classified as a schedule 1 substance just like marijuana, which classified the compound as having “high abuse potential, no medical use, and severe safety concerns”.
Since Epidiolex was approved, the FDA was then under obligation to reclassify or reschedule CBD as a schedule 2,3,4 or 5 substance within 90 days.
Shortly after the CBD-based medicine was approved by the administration, FDA commissioner Scott Gottlieb said that this was an important moment for the future exploration into medical marijuana, stating that “advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies”.
Experts are hopeful that Epidiolex gaining FDA approval will spark new leads into the potential of medical marijuana and CBD as a medical treatment.
Epidiolex had undergone three large scale medical trials before the FDA considered approving it for widespread sale earlier this year.
Researchers found strong evidence to support the fact that pharmaceutical-grade cannabidiol in the drug had the ability to substantially reduce some of the worst symptoms of Lennox-Gastaut syndrome and Dravet Syndrome, two of the rarest cases of childhood-onset epilepsy.
While treatment with Epidiolex is likely to cost $32,000 a year, the declassification of CBD as a schedule 1 drug means that it will be more widely available from dispensaries for people who cannot afford the drug or cannot acquire a prescription.
However, researchers and experts are warning against buying low-grade CBD from non-pharmaceutical sources. It is also possible that on co-pay insurance, Epidiolex may cost less than buying CBD straight from a cannabis dispensary or online source.
In a study published last year in the Journal of the American Medical Association, researchers found that across the 84 CBD products they tested from 31 online sellers, 18 of the samples tested positive for THC while roughly 7/10 had different levels of CBD than what was listed on the label.
While this ruling by the FDA could result in the mass production of more low-grade CBD products, experts are excited to see what developments can be made on the back of Epidiolex’s success.