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Medical Affairs

Information and resources for healthcare professionals.

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MEDICAL INFORMATION

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For questions about scientific and clinical information regarding Greenwich Biosciences products, submit a medical request form or contact Medical Information by phone.

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Explore pertinent response documents and publications for Greenwich Biosciences product(s).

 

 

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EPIDIOLEX® (cannabidiol)

The first and only FDA approved cannabidiol.

Recent Publications

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.

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 Website

Product Pipeline

View the Greenwich Biosciences Pipeline for information about medicines in development.

Learn More

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.

Search ClinicalTrials.gov

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

Educational Resources

This section contains helpful resources including videos, symposia, and downloadable educational materials about the science behind our mission.

CME/CE

The Pharmacist Role in Treating Dravet Syndrome and Lennox-Gastaut Syndrome

Jacquelyn Bainbridge, PharmD, FCCP

Start CME/CE

Expires: August 23, 2022

Navigating Cannabidiol Use in Seizure Disorders: A Roadmap for Managed Care and Specialty Pharmacists

Jacquelyn L. Bainbridge, PharmD, FCCP; Sheldon J. Rich, R.Ph., Ph.D.

Start CME/CE

Expires: November 21, 2020

Real‐World Approaches to Cannabinoids in Pediatric‐Onset Epilepsy: What Do the Data Tell Us?

 

Anup Patel, MD

Start CME/CE

Medscape website will ask you to log in, but registration is free.
Expires: December 19, 2020

Finessing the Discussion During the Transition of Care in Pediatric Epileptic Encephalopathies

Lawrence W. Brown, MD; Gregory D. Cascino, MD; Christina SanInocencio, MS

Start CME/ABIM MOC/CE

Medscape website will ask you to log in, but registration is free.
Expires: February 7, 2021

Getting the Conversation Right in Epilepsy: How to Talk With Your Patients About Cannabinoids

Anup D. Patel, MD

Start CME/ABIM MOC

Medscape website will ask you to log in, but registration is free.
Expires: May 6, 2021

Cannabidiol (CBD): A Tale of Two Products

C. Michael White, Pharm D

Start CME/CE

Expires: May 15, 2021

CPNP symposium: Cannabis Confusion: Sorting Out the Differences and Legality of CBD, Marijuana and Hemp Products

Jacquelyn L. Bainbridge, PharmD, FCCP; Laura Borgelt, PharmD, MBA, FCCP, BCPS

Start CME/CE

Expires: May 20, 2021

Assessing Practice Patterns in the Management of Tuberous Sclerosis Complex

Elizabeth A. Thiele, MD, PhD

Start CME/ABIM MOC

Medscape website will ask you to log in, but registration is free.
Expires: May 29, 2021

A Quick Reference Guide to the Therapeutic Use of Cannabinoids in Epilepsy

Orrin Devinsky, MD

Start CME/ABIM MOC/CE

Medscape website will ask you to log in, but registration is free.
Expires: June 8, 2021

Test Your Expertise in Rare, Pediatric-Onset Epilepsies: An Online Medical Simulation

Tyler Elyse Gaston, MD; Anup Patel, MD

Start CME

Medscape website will ask you to log in, but registration is free.
Expires: June 11, 2021

Pharmaceutical- vs Dispensary-Sourced Cannabinoids: What's the Difference?

Daniel Friedman, MD, MSc; Anup D. Patel, MD

Start CME/ABIM MOC/CE

Medscape website will ask you to log in, but registration is free.
Expires: March 21, 2019

The Basis of Cannabinoid Therapeutics: What You Need to Know

Ethan Russo, MD; Barry Gidal, PharmD

Start CME/CE

Medscape website will ask you to log in, but registration is free.
Expires: October 31, 2019

Cannabinoids In Epilepsy: New Horizons for Improving the Management of Severe Seizure Disorders

Jacquelyn L. Bainbridge, PharmD, FCCP

Start CME/CE

Expires: December 10, 2019

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

Start CME

Medscape website will ask you to log in, but registration is free.
Expires: December 17, 2019

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.

About us

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