By Colin Kellaher

 

Relmada Therapeutics Inc. on Tuesday said the U.S. Food and Drug Administration granted fast-track designation to REL-1017, the company's lead program, as a monotherapy for the treatment of major depressive disorder, or MDD.

The Coral Gables, Fla., clinical-stage biotechnology company, which is currently conducting Phase 3 studies of REL-1017 as monotherapy and adjunctive therapy for the mental-health disorder, said available treatments remain inadequate for the majority of patients with MDD.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

August 09, 2022 09:06 ET (13:06 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
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