Access to Investigational Medicines Prior to Regulatory Approval
Greenwich Biosciences, Inc., is the US Subsidiary of GW Pharmaceuticals PLC
At Greenwich Biosciences, listening to patients has been at the heart of our efforts. We are determined to respond to the needs of patients with severe and highly treatment resistant forms of epilepsy, and have focused our efforts on the development of Epidiolex® an oral formulation of cannabidiol, or CBD, as a potential new treatment option to address this important medical need. Development efforts are also in various stages for other cannabinoid product candidates.
Prior to approval, 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 treatment of patients with a serious or immediately life-threatening disease or a condition which lacks therapeutic alternatives.
- The FDA has authorized access for over 1100 treatment resistant epilepsy patients to receive Epidiolex through Investigational New Drug applications to independent physician investigators as well as programs supported by several US states. This is the largest EAP, or Compassionate Use Program, within epilepsy, and we are proud to partner in this unprecedented effort by providing free investigational medication to patients enrolled in this program.
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
How to obtain more information about Expanded Access
- Though we are pleased to partner with physicians and states on the initiative, the EAP is not a corporate-sponsored program. It is led by physicians and/or states.
- Not all investigator or state led EAP programs are listed on clinicaltrials.gov website. This is subject to change, so we recommend searching the website by compound name: GWP42003-P, or the commonly used term, Epidiolex.
- Please note that not all compounds listed as cannabidiol or CBD are the same. For this reason, we use the name Epidiolex to refer to our specific oral formulation under investigation.
- Currently, we are not reviewing new physician applications, except in emergency, life-threatening situations.
- Please note, all cannabis derived substances, including Epidiolex, 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.
For Physicians and other Healthcare Professionals
If you would like additional information regarding the Epidiolex EAP, or another type of compassionate access for your patients, please click here to contact our medical team.
- You should expect to receive a 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 our 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.
For Non-Healthcare Professionals.
If you would like additional information regarding the Epidiolex EAP, please have your physician contact us by clicking here.
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.
This Expanded Access policy is subject to change at any time. Please check the most recent policy posted on our website.
Greenwich Biosciences, Inc. Expanded Access Program February 10, 2017