A clinical study of an adjunctive therapy for depression

The Relight clinical research program is testing an investigational medication for people living with Major Depressive Disorder (MDD).

A novel oral study drug is being investigated for patients with major depressive disorder (MDD) who have an inadequate response to their current antidepressant therapy (ADT)

Relmada study 302, and 304, are Phase 3, randomized, double-blind, placebo-controlled studies study evaluating a novel add-on therapy in patients with major depressive disorder (MDD).Participants will be randomized to receive the oral study drug or a placebo pill and will continue to take their current antidepressant at a stable dose.

The study lasts up to 9 weeks including a 4-week treatment period and includes 7 visits to the study site, with an opportunity to continue to take the study drug with our Expanded Access Program.

The study drug, REL-1017 (esmethadone) is an oral, once-daily, uncompetitive N-methyl-D-aspartate receptor (NMDAR) antagonist being studied as an adjunctive treatment for MDD

In two completed Phase 3 studies and an Open Label long-term safety study, REL-1017 displayed a favorable safety & tolerability profile with no evidence of abuse potential and no meaningful cardiovascular or neurological side effects. There were no signals of weight gain or sexual dysfunction.

Key inclusion criteria

Adults 18 to 65 years of age, inclusive
Diagnosed with MDD without psychotic features, with a current major depressive episode (MDE) of ≥8 weeks and ≤24 months
Inadequate response (less than 50% symptom reduction) to 1 to 3 ADTs in the current MDE
On a stable dose of ADT for ≥6 weeks

Key exclusion criteria

History of other mental health disorders such as posttraumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD), schizophrenia
History of psychotic episodes or manic/hypomanic episodes
Psychiatric hospitalization during the current MDE
At significant risk for suicide

For all references, please visit relmada.com/our-portfolio/data-and-publications

About Relmada Therapeutics

Relmada Therapeutics is a late-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). Relmada's experienced and dedicated team is committed to making a difference in the lives of patients and their families.

Relmada.com