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Relmada Therapeutics, Inc. announced that the Investigational New Drug (IND) application for d-Methadone (REL-1017 dextromethadone), the company's novel, N-methyl-D-aspartate (NMDA) receptor antagonist, has been cleared by the U.S. Food and Drug Administration (FDA). The company is now authorized to advance the development program for d-Methadone to a Phase 2a proof of concept clinical study in patients with treatment resistant depression (TRD).
"FDA acceptance of our IND for d-Methadone represents a very significant milestone for Relmada and further validation of our efforts to develop innovative therapies with the potential to address some of the most challenging unmet needs in the treatment of depression," said Richard Mangano, Ph.D., chief scientific officer of Relmada. "Building on the findings from our single- and multiple-ascending dose studies that demonstrated a targeted dose range without the side effects associated with racemic methadone and ketamine, d-Methadone has the potential to represent a paradigm shift in the treatment of major depressive disorder in the years ahead."
The planned phase 2a, randomized, double-blind, placebo-controlled study will include patients with major depressive disorder. The study will assess changes in depressive symptoms as well as the safety, tolerability and pharmacokinetics of two dose levels of REL-1017 as adjunctive treatment in patients during a seven-day dosing period and 14-day observation period.
