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Relmada Therapeutics Announced Publication of Results from the Phase 3 Reliance I Study of REL-1017 in The Journal of Clinical Psychiatry
CORAL GABLES, Fla., June 18, 2024 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the
About this update from Relmada Therapeutics, Inc.
[{"type":"text","content":"CORAL GABLES, Fla., June 18, 2024 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), 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 Journal of Clinical Psychiatry. The article is titled, \"Efficacy and Safety of Esmethadone (REL-1017) in Patients with Major Depressive Disorder and Inadequate Response to Standard Antidepressants: A Phase 3 Randomized Controlled Trial\", and is available online at Link To Title.\n\n \n \n \n \n \n \n\n \n\"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 Maurizio Fava, MD, the Principal Investigator of Reliance I.\nAbout Reliance I\nReliance 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. \nAs reported in December 2022, Reliance I did not meet the primary endpoint in the ITT analysis, yet, REL-1017 showed a statistically significant improvement in response rate compared to placebo (P = .044) and an encouraging nonsignificant trend for improvement in remission rate (P = .076). In the PP prespecified supportive analysis that excluded protocol noncompliant patients for reasons unrelated to REL-1017 adverse events (AE), results trended toward a more favorable outcome (MD CFB = 3.1; P =.051, ES = 0.29). Further, in post hoc analyses of patients with severe depression (MADRS score ≥35 at baseline), significant improvement as measured occ...