The Epidiolex® (cannabidiol or CBD) Clinical Program
We are committed to developing new medicines to treat rare, treatment-resistant epilepsy conditions where there are limited or in some cases, no approved treatment options.
Epidiolex (CBD) is our lead cannabinoid product candidate and is a proprietary oral solution of pure plant-derived cannabidiol, or CBD. Our Epidiolex (CBD) development is initially concentrating on severe, orphan, childhood-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS).
Epidiolex (CBD) development includes two distinct programs:
Phase 3 Pivotal Trials
- We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex (CBD) to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine. Target indications currently include Dravet syndrome, Lennox-Gastaut syndrome, Tuberous Sclerosis Complex, and Infantile Spasms. In these trials, eligible patients are randomly assigned to receive Epidiolex (CBD) or placebo added to their current treatment and evaluated over a specific period of time.
- The current Phase 3 pivotal trial program for Epidiolex (CBD) includes two Phase 3 trials in Dravet syndrome, two in LGS, one in TSC, and one in IS. The first three of these Phase 3 trials, one in Dravet syndrome and two in LGS, has been completed and top-line results have been reported.
- To learn more about the Epidiolex (CBD) clinical trials please see the ClinicalTrials.gov website here.
- If you're a US physician interested in reaching out to the US medical affairs team, click here.
FDA-authorized, Independent Physician-led Program for which we supply Epidiolex* (CBD)
- The FDA may authorize expanded access programs to facilitate access to investigational drugs for treatment use for patients with a serious or immediately life-threatening disease or condition who lack therapeutic alternatives. This is done through FDA granting Investigational New Drug (IND) applications.
- The FDA has granted individual patient emergency INDs to physicians as well as intermediate or treatment INDs to physicians and state programs to treat groups of patients suffering from intractable epilepsy with Epidiolex (CBD).
- The most recent physician-reported data from this Expanded Access Program was published in an article which appeared in The Lancet Neurology. March 2016 15(3):270-278
We are committed to respecting the primary role of healthcare providers in the treatment of epilepsy disorders. Therefore, we cannot respond to medical questions about your personal health situation, nor can we accept private medical information. Please contact your healthcare provider with any questions pertaining to your or a family member's medical condition.
For Non-Healthcare Professionals
If you are interested in participating in one of our sponsored clinical trials, please have your physician contact us by clicking here.
For Physicians and/or Sites Interested in Clinical Trials
If you are interested in finding out more about our current clinical trials or new investigator-initiated clinical research, please send site and investigator information to our team by clicking here.
Epidiolex (CBD) is an investigational drug not approved for any indication.