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.
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.
Relmada Announces FDA Fast Track Designation for d-Methadone for Adjunctive Treatment of Major Depressive Disorder [news release]. New York, NY: Relmada Therapeutics, Inc; released April 13, 2017. http://www.prnewswire.com/news-releases/relmada-announces-fda-fast-track-designation-for-d-methadone-for-adjunctive-treatment-of-major-depressive-disorder-300439275.html. Accessed on May 4, 2017.
This article originally appeared on MPR