Relmada Therapeutics

Available Therapies via Single-Patient EA 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.