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Relmada Therapeutics Announces Efficacy and Safety Results from the Phase 3 Long-Term Study of REL-1017 in Major Depressive Disorder
Patients newly treated with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and
About this update from Relmada Therapeutics, Inc.
[{"type":"text","content":"Patients newly treated with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairmentLong-term dosing with REL-1017 was well-tolerated, with low rates of adverse events and discontinuations due to adverse events, and no new safety signals were detectedCORAL GABLES, Fla., Sept. 20, 2023 /PRNewswire/ -- Relmada Therapeutics, Inc. (Nasdaq: RLMD), a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced efficacy results for the de novo (or new to treatment) patients (204 patients) and safety results for all subjects (627 patients) from the Phase 3, long-term, open-label, registrational trial (Study 310) of REL-1017 in patients with Major Depressive Disorder (MDD). Detailed efficacy data for rollover population in the study will be presented when available.\n\n \n \n \n \n \n \n\n \nPatients treated daily with REL-1017 for up to one year experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms and associated functional impairment. REL-1017 was well-tolerated with long-term dosing, showing low rates of adverse events and discontinuations due to adverse events. No new safety signals were detected.\n\"These efficacy and safety results represent real-world potential outcomes for MDD patients when treated with REL-1017,\" said Cedric O'Gorman, MD, Chief Medical Officer of Relmada. \"The rapid and sustained therapeutic effects achieved with REL-1017 suggest the significant therapeutic potential of this promising late-stage product candidate as a mechanistically novel and differentiated treatment for MDD. The early magnitude and trajectory of clinical improvement remain consistent across all trials conducted to date. The long-term sustained clinical improvement, coupled with an extremely well-tolerated profile, adds to our enthusiasm for this agent as a potential therapeutic option for patients and prescribers.\"\nStudy REL-1017-310 was a long-term, open-label, non-comparative, registrational Phase 3 trial designed to evaluate the efficacy and safety of REL-1017 administered once-daily in patients with MDD for up to one year. In total, 627 patients were enrolled, comprising 423 patients who rolled over (rollover patients/subjects) from placebo-controlled tria...