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Relmada Therapeutics Announces Outcome of End-of-Phase 2 Meeting with FDA for REL-1017 for Adjunctive Treatment of Patients with Major Depressive Disorder
Phase 3 Program Can Advance and the Company Plans to Initiate Registration Studies in the Fourth Quarter of 2020 NEW YORK, May 27, 2020 /PRNewswire/ --
About this update from Relmada Therapeutics, Inc.
[{"type":"text","content":"Phase 3 Program Can Advance and the Company Plans to Initiate Registration Studies in the Fourth Quarter of 2020\n\n\nNEW YORK, May 27, 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 completion of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on its development program of REL-1017 (dextromethadone) for the adjunctive treatment of major depressive disorder (MDD) patients. The Company can proceed into Phase 3 without conducting additional clinical studies, and the FDA and Relmada are aligned on all key aspects of this planned Phase 3 program. Key points of the Phase 3 program discussed and agreed upon by the FDA and the Company include:\n\n \n \n \n \n \n \n\n \nThe Company can proceed to Phase 3 registration studies. The program will consist of two placebo-controlled clinical trials with the first trial expected to commence in the fourth quarter of this year. The indication to be assessed will be adjunctive treatment in MDD patients who have failed at least one prior treatment in the current depression episode. The primary endpoint to be evaluated in the Phase 3 program will be the change from baseline on the Montgomery and Asberg Depression Rating Scale (MADRS) at day-28 for REL-1017 compared to placebo. Success on this endpoint would support the use of REL-1017 for chronic treatment, with the collection of sufficient safety data, if approved. The change from baseline on the 7-day MADRS will serve as a key secondary endpoint to provide data on the time to onset of treatment effect; statistically significant separation between REL-1017 and the control group was achieved by Day 4 in the Phase 2 proof-of-principle trial concluded in 2019. The REL-1017 dose tested in the Phase 3 program will be 25mg once a day. The pharmacodynamic relationship in the Phase 2 trial support equivalence of the 25 mg and 50 mg doses. As such, each of the Phase 3 registration trials will be designed as a two-arm study. No PK bridging studies are required to support the transition from the powder-in-solution formulation of REL-1017 utilized in the Phase 2 trial to the tablet formulation that will be used in the Phase 3 program. Abuse liability studies to determine the scheduling ...