, /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: ), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced the publication of REL-1017 clinical data from the Reliance I Study in the peer-reviewed journal, . The article is titled, " ", and is available online at "The overall results from this trial are clearly consistent with the evidence, produced by the prior phase 2 trial, for the efficacy, safety, and tolerability of esmethadone as a promising antidepressant for the adjunctive treatment of major depressive disorder.
The side-effect profile of esmethadone compares quite favorably with the side effects of the currently FDA-approved adjunctive treatments for MDD.," said , MD, the Principal Investigator of Reliance I. Reliance I was a 28-day, Phase 3, randomized, double-blind, placebo-controlled study to evaluate REL-1017 (75 mg on day 1, followed by 25 mg daily on days 2 through 28) compared to placebo as adjunctive treatment in patients with major depressive disorder (MDD).
The intent-to-treat (ITT) population comprised 227 randomized patients; the per protocol (PP) population comprised 198 patients completing treatment. The primary efficacy measure was mean difference (MD) between REL-1017 and placebo in change from baseline (CFB) through day 28 in the Montgomery-Asberg Depression Rating Scale (MADRS) score. As reported in , Reliance I did not meet the primary endpoint in the ITT analysis, yet, REL-1017 showed a stat.
