EPIDIOLEX® (cannabidiol) CV
EPIDIOLEX® (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older.
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Recent Publications
EPIDIOLEX® (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older.
Below are links to publications about EPIDIOLEX from the Phase 3 studies that supported approval by the US Food and Drug Administration (FDA).
The links to these reprints are being provided for educational purposes only. The data reported in these publications may differ from or may not be included in the full Prescribing Information. See link to full prescribing information above. Prescription drugs used outside of their approved indications may not be eligible for reimbursement by third-party payers including Medicare, Medicaid or similar federal or state programs. Financial and conflict of interest disclosures are included within each respective publication.
EPIDIOLEX Phase 3 Publications
- Thiele EA, Marsh ED, French JA, et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018
- Devinsky O, Patel AD, Cross JH, et al. Effect of cannabidiol on drop seizures in the Lennox-Gastaut syndrome. N Engl J Med. 2018
- Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for drug-resistant seizures in the Dravet syndrome. N Engl J Med.2017
Cannabinoid Educational Resources
For more information about cannabinoids, access the resources at the links below.
Find additional information for healthcare professionals, patients, and caregivers about epilepsy, Dravet syndrome, and Lennox-Gastaut syndrome.
Cannabinoid Clinical WebsiteDownloadable Cannabinoid Glossary
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Clinical Trials
Access ClinicalTrials.gov for a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. It is a service of the US National Institutes of Health.
Educational Grant Requests
Greenwich Biosciences is proud to support continuing medical education for healthcare professionals, helping to ensure that their patients receive the highest quality of care.
Our primary areas of focus for educational support are cannabinoid science and disorders of the central nervous system, including epilepsy. This global program is open to physicians, researchers, and institutions interested in conducting external research.
Please send your requests to grants@greenwichbiosciences.com.
Grant requests should include:
• A letter of request including the amount you are requesting
• A detailed proposal including a draft agenda, needs assessment, the target audience, number of participants anticipated, and accreditation (if applicable)
• Overall budget for the program
• Any additional information to aid in our review
Investigator Initiated Research Proposals
We welcome innovative proposals for EPIDIOLEX research. To submit an application, please download the form below.
Greenwich Biosciences will retain drug-related IP on all IIR. Please check with your institution before applying.
Educational Resources
This section contains helpful resources including videos, symposia, and downloadable educational materials about the science behind our mission.
Continuing Medical Education
The Basis of Cannabinoid Therapeutics: What You Need to Know
Ethan Russo, MD; Barry Gidal, PharmD
Medscape website will ask you to log in, but registration is free.
Pharmaceutical vs Dispensary-Sourced Cannabinoids: What's the Difference?
Daniel Friedman, MD, MSc; Anup Patel, MD
Medscape website will ask you to log in, but registration is free.
Straight Talk: The Intersection of Clinical and Patient Perspectives on Cannabinoids for Epilepsy
Tracy A. Glauser, MD; Orrin Devinsky, MD; Tracy Dixon Salazar, PhD; Anup D. Patel, MD; Elizabeth A. Thiele, MD, PhD
Medscape website will ask you to log in, but registration is free.
Cannabinoids In Epilepsy: New Horizons for Improving the Management of Severe Seizure Disorders
Jacquelyn L. Bainbridge, PharmD
Expanded Access
Participation in one of our clinical trials is the optimal way for patients to gain access to our investigational medicines. However, we understand that some patients may not be able to participate in a clinical trial and may seek access to investigational medicines before they are approved. For such patients, the FDA may authorize Expanded Access Programs (EAPs), also known as Compassionate Use Programs, to facilitate access to investigational drugs for the treatment of patients with a serious or immediately life-threatening disease or a condition which lacks therapeutic alternatives.
To obtain more information about Expanded Access, click here.
How To Obtain More Information About Expanded Access
General information
- Currently, we are not reviewing new physician applications.
- An EAP may either be a corporate-sponsored program or be led by physicians and/or states.
- Not all investigator or state-led EAPs are listed on the clinicaltrials.gov website.
- Please note, all cannabis-derived investigational therapies not yet approved by FDA are considered Schedule I controlled substances in the US and specific DEA permits are required to prescribe and dispense the product, even in such emergency situations. This is true regardless of individual state law.
Criteria Used For Considering Requests For Expanded Access
Greenwich Biosciences will consider granting expanded access to an investigational product only if all of the following criteria are met:
- The patient has a serious or immediately life-threatening disease or condition.
- The patient is ineligible, or otherwise unable to, participate in a clinical trial.
- There is no comparable or satisfactory alternative therapy for the disease or condition, or such therapies have already been tried without response.
- Sufficient clinical evidence of safety and effectiveness in the indication has been established, the potential benefit justifies the potential risks, and the potential risks are not unreasonable within the context of the disease or condition.
- Product is under active development in the indication and expanded access will not interfere with the development of the product.
- Greenwich Biosciences has adequate supply of investigational product.
- There is a regulatory mechanism in the country or region to support expanded access.
- The program must be discontinued as soon as feasible when approval of the drug is achieved in the country.
- Once a regulatory agency approves a medicine for commercial use, existing expanded access programs will be phased out
In addition to the criteria noted above, Greenwich Biosciences reserves the right to evaluate expanded access requests on additional criteria on a case-by-case basis.