On April 6 2020 GW Pharmaceuticals and it’s US Subsidiary Greenwich Biosciences Inc. announced that their cannabidiol based medicine EPIDIOLEX, which is a oral solution, is no longer a controlled substance. While there are no other CBD medicines with FDA approval, this announcement places EPIDIOLEX as the first cannabidiol based medicine that gets FDA approval.
The DEA also confirmed the non- controlled status of the medicine, fully establishing that the medicine is no longer a controlled substance under the federal Controlled Substances Act.
Epidiolex is a cannabidiol based medicine that gets FDA approval for the treatment of seizures associated with Lennox-Gausetaus Syndrome or Dravet syndrome in patients two years of age or older. As explained before on this page, CBD is the non-psychoactive cannabinoid from the cannabis sativa plant, and it has several beneficial effects while not producing any high. Epidiolex contains a pure form of the cannabinoid derived from marijuana plants.
What is Epidiolex good for?
In the official FDA press release it is mentioned:
“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. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D. “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.
Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
In terms of testing the efficiency of the medicine prior to it’s approval: “Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo. The most common side effects that occurred in Epidiolex-treated patients in the clinical trials were: sleepiness, sedation and lethargy; elevated liver enzymes; decreased appetite; diarrhea; rash; fatigue, malaise and weakness; insomnia, sleep disorder and poor quality sleep; and infections.”
What changed for the cannabidiol based medicine?
After receiving the first FDA approval, Epidiolex was in Schedule V of the CSA, GW was than got a post-approval supplement with FDA to remove Schedule V designation for the medication.
This approval from the FDA along with the letter from the DEA means that all federal contralled-substance restrictions have need removed. The changes take place immediately and the company starts to implement the changes at state level in the entire distribution network. Once each state is ready, prescriptions for EPIDIOLES wil be valid for one year making it much more accessible. More doctors will now be able to prescribe this medicine without the requirements of state prescription drug monitoring programs.
CBD is now in the spotlight giving a chance for researchers to examine it’s effects. Furthermore, this are good news for the cannabis community and a glance of hope that more research about the properties of cannabinoids will be made and new medicine will appear and have a chance at approval for prescription.