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Individual Patient Esmethadone (REL-1017) Expanded Access Program

No Longer AvailableN/A

Sponsor: Relmada Therapeutics, Inc.

Conditions: Major Depressive Disorder, Depression

Interventions: REL-1017

To provide expanded access of esmethadone (REL-1017) to patients with a serious or immediately life-threatening disease or condition that may potentially benefit from esmethadone (REL-1017) who do not have access to other effective therapy and are not eligible for other clinical trials with esmethadone (REL-1017).

Eligibility overview

Sex: ALL

Study type: EXPANDED_ACCESS

Eligibility criteria

Inclusion Criteria:

* Patients who may potentially benefit from treatment with esmethadone (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.

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 QTc prolongation.
* History of allergy or hypersensitivity to methadone or related drugs.
* Pregnant or planning to become pregnant.
* Breast-feeding or planning to breast-feed.