Patent Further Expands Company's Intellectual Property Protection for REL-1017 a Novel NMDA Receptor Antagonist, in a Major Global Market
NEW YORK, June 23, 2020 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced the receipt of a Notice of Allowance from the Canadian Intellectual Property Office for Relmada's patent application number, 2,893,238, titled, "d-Methadone for the Treatment of Psychiatric Symptoms." The patent that will issue from this allowed application provides broad coverage in Canada for REL-1017 (d-methadone, dextromethadone,), a novel N-methyl-D-aspartate (NMDA) receptor antagonist, for the treatment of symptoms associated with a wide range of psychological and psychiatric disorders, including depression, anxiety, fatigue, and mood instability.
"This patent, which has previously been granted in the U.S., EU, Australia, China, Hong Kong, Mexico, and South Korea, advances our objective of further strengthening our intellectual property portfolio in multiple key markets around the world," said Sergio Traversa, CEO of Relmada Therapeutics. "Canada represents a significant market opportunity for Relmada, as published research indicates that the 12 months' prevalence rate of major depressive disorder (MDD) in Canada was 4.7%, and the lifetime prevalence rate was 11.2%¹. We look forward to initiating our Phase 3 program for REL-1017 for the adjunctive treatment of MDD in the fourth quarter of this year."
Relmada recently completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on its development program of REL-1017 for the adjunctive treatment of MDD patients. Based on the FDA feedback, the Company can proceed into Phase 3 without conducting additional clinical studies, and the FDA and Relmada are aligned on all key aspects of the planned Phase 3 program.
About REL-1017 (dextromethadone)
REL-1017 is a non-competitive N-methyl-D-aspartate Receptor (NMDAR) antagonist with the potential to be the first oral single agent NMDAR antagonist approved for the adjunctive treatment of MDD. In a Phase 2 trial, REL-1017 demonstrated rapid onset and sustained antidepressant effects with statistically significant improvements as compared to placebo on efficacy measures. The Phase 2 study also confirmed the favorable safety and tolerability profile of REL-1017 observed in previously completed Phase 1 studies. In April 2017, the FDA granted Fast Track designation for dextromethadone for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines to address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. Relmada's lead program, REL-1017 (dextromethadone) is an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
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¹ Knoll, A. D., & MacLennan, R. N. (2017). Prevalence and correlates of depression in Canada: Findings from the Canadian Community Health Survey. Canadian Psychology/Psychologie Canadienne, 58(2), 116–123.