Relmada Therapeutics Inc. (Nasdaq: RLMD) announced the publication of “promising” REL-1017 clinical data from the Reliance I Study in the peer-reviewed journal, The Journal of Clinical Psychiatry.
“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,” said Maurizio Fava, MD, the principal investigator of Reliance I. “The side-effect profile of esmethadone compares quite favorably with the side effects of the currently FDA-approved adjunctive treatments for MDD.”
The results were published in an article 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.”
According to the National Library of Medicine, esmethadone belongs to a novel class of NMDAR antagonists with therapeutic uses. Other drugs in this category are esketamine, ketamine, dextromethorphan, and memantine.
Reliance I study
Relmada said that 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 company said in a statement, “As 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).”
When patients who were noncompliant for “reasons unrelated to … adverse events, results trended toward a more favorable outcome,” the company noted.
Relmada also said that the side effects remained consistent and compared favorably to other FDA-approved treatments for MDD. The company also said that there were no signals for the potential abuse of the drug.
Relmada continues to enroll patients in both ongoing REL-1017 trials. including Reliance II (Study 302), with top-line data anticipated in the second half of 2024, and Relight (Study 304), with top-line data anticipated approximately six months after the completion of Study 302.
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