Relmada Therapeutics

To provide expanded access of REL-1017 to patients with MDD who do not have access to other effective therapy and are not eligible for other clinical trials with REL-1017.
Inclusion Criteria:
• Patients with Major Depressive Disorder who may potentially benefit from treatment with REL-1017 as determined by the treating physician.
• Have undergone appropriate standard treatments without success and in the opinion of the treating physician no comparable or satisfactory
alternative treatment is available to treat the disease or condition.
• Are ineligible or unable to participate in any ongoing clinical study of the investigational product.
• Condition for which, in the opinion of the treating physician, there is sufficient evidence of a potential benefit from the use of the investigational product, and that potential benefit outweighs the known or anticipated
risks.
• There is adequate information to support appropriate dosing for special population patients such as pediatric, elderly, renal or hepatic disease, etc.
Exclusion Criteria:
• History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
• History of allergy or hypersensitivity to methadone or related drugs.
• Pregnant or planning to become pregnant.
• Breast-feeding or planning to breast-feed.