The Food and Drug Administration (FDA) has granted Fast Track designation for d-Methadone (REL-1017 dextromethadone; Relmada) for the adjunctive treatment of major depressive disorder.

REL-1017 is Relmada’s investigational, rapid-acting, oral N-methyl-D-aspartate (NMDA) receptor antagonist under development for the treatment of depression, neuropathic pain, and other potential CNS pathological conditions. The company has completed a Phase 1 study for REL-1017 and intends to initiate a randomized, double-blind, placebo-controlled Phase 2a trial in patients with major depressive disorder to assess its efficacy, safety, tolerability and pharmacokinetics. 

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REL-1017, an enantiomer of racemic methadone, exerts its action by inhibiting the activation of NMDA receptors while possessing no opioid activity at therapeutic doses.

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