The purpose of this policy is to describe the requirements for Expanded Access to Relmada investigational product REL-1017 to patients outside of a clinical study.
Any use of a Relmada investigational product outside a clinical study in a country must be in accordance with local laws and regulations governing such programs, including Relmada policies and procedures.
In general, where permitted by local regulation, the investigational product supplied via Expanded Access may no longer be provided by Relmada when it becomes commercially available via the local healthcare system.
To be eligible for access to an investigational product, patients must meet the following criteria:
In addition to the patient eligibility requirements, the investigational product must meet the following criteria:
The physician(s) attending to the patient(s) who is/are receiving an investigational product through expanded access is (are) properly licensed and fully qualified to administer the product. The physician must agree in writing to comply with:
A treating physician may submit questions or requests regarding expanded access to REL-1017 via email at email@example.com. This mailbox is monitored by Relmada.firstname.lastname@example.org
For additional information on clinical studies with REL-1017, please see the clinical trials.gov link below:REL-1017 clinical trials