Will the FDA approve its first CBD-based drug? Epidiolex, a pharmaceutical made by UK-based company GW Pharmaceuticals plc (known as Greenwich Biosciences in the US), is a CBD-based drug that’s targeted specifically to patients who suffer seizures due to either Dravets syndrome or Lennox-Gastaut syndrome. The New Drug Application for Epidiolex was just submitted to the Food and Drug Administration, an undertaking that is no small event.
Since there are no related drugs that are approved by the FDA, the creators of Epidiolex had to submit thousands of documents supporting the medicinal use of the drug, spanning a variety of topics. The documents included data and details for preclinical, clinical, manufacture and distribution, and more. It also included the company’s clinical data involving 1,500 patients, 400 of whom have been using Epidiolex for more than a year.
The FDA has 60 days to OK the application; if they do, additional reviews, facilities inspections, and potential rescheduling of the drug could take place. If all of that goes smoothly, the drug could be available in US markets this time next year. The company expects “significant demands” from the patients the drug is meant to help: in the US, there are 33,000 people who suffer from Lennox-Gestaut syndrome, and 8,000 who have Dravets syndrome. The company is also running trials to determine if the drug will be useful for other conditions, such as infantile spasms.
Why does it matter? If the FDA approves, this will be the first federally-recognized and approved drug that’s derived from the cannabis plant. All forms of cannabis are currently classified as Schedule I drugs: illegal, and without any medical benefit. Obviously, many states have taken an alternative stance, legalizing medical marijuana for an array of conditions, all supported by research. If a cannabis-derived drug like Epidiolex, which is based on CBD and therefore non-psychoactive, is recognized for it’s medicinal benefit and rescheduled federally, it’s a slippery slope from there.