Relmada Therapeutics Announces FDA Acceptance of IND and Authorization to Commence Phase 2a Clinical Trial for d-Methadone
January 26, 2017 at 04:11 am IST
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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). 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.
Relmada Therapeutics, Inc. is a clinical-stage biotechnology company addressing diseases of the central nervous system (CNS), with a focus on major depressive disorder (MDD). The Company is focused on the development of esmethadone (d-methadone, dextromethadone, REL-1017), an N-methyl-D-aspartate (NMDA) receptor antagonist. Esmethadone, an isomer of methadone, is a new chemical entity (NCE) that potentially addresses areas of high unmet medical need in the treatment of central nervous system (CNS) diseases and other disorders. The Companyâs lead program, REL-1017, is a NCE and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission. REL-1017 is in late-stage development as an adjunctive treatment for MDD in adults. Its esmethadone, is being developed as a rapidly acting, oral agent for the treatment of depression and other potential indications.
RELMADA THERAPEUTICS, INC. 
