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.

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. 

For Physicians and other Healthcare Professionals

If you would like additional information regarding expanded access for your patients, please click here to contact our medical team or by contacting Greenwich Biosciences Medical Information by phone at +1-833-424-6724 (833-GBIOSCI).

  • You should expect to receive an initial response within 2 business days.
  • Only applications for emergency, life-threatening situations will be reviewed at this time.
  • Applications will be evaluated by an internal team comprising experts from medical affairs, legal/compliance, and other internal reviewers.
  • The review team will consider patient need, the availability of clinical evidence to support the request, product availability, and legal and regulatory requirements.

Physicians interested in commercially available products should contact
+1-833-GBNGAGE (426-4243).

For Patients and Caregivers

If you would like additional information regarding expanded access to a Greenwich Bioscience product in development, please have your physician contact us.

Additional information regarding expanded access for individual Greenwich Biosciences’ products may be found on ClinicalTrials.gov.

Find an open clinical trial on clinical trials.gov (all sponsors, including Greenwich Biosciences, Inc.)

We are committed to respecting the primary role of healthcare providers in the treatment of rare and severe neurological diseases. 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.

This Expanded Access policy is subject to change at any time.

Greenwich Biosciences, Inc. Expanded Access Program April 2019