Relmada Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to REL-1017, the Company's novel NMDA receptor (NMDAR) channel blocker, as a monotherapy for the treatment major depressive disorder (MDD). The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. To qualify, a fast track drug must show some advantage over current therapy, such as superior effectiveness, effect on serious outcomes or improved effect on serious outcomes, and avoiding serious side effects of an available therapy.

A Fast Track designation allows for more frequent meetings with the FDA to discuss the drug's development plan and the design of the proposed clinical trial to ensure collection of appropriate data needed to support drug approval. In addition, a drug that receives Fast Track designation is eligible for Accelerated Approval and Priority Review, if relevant criteria are met, as well as Rolling Review, which enables a drug company to submit portions of the New Drug Application to the FDA as they are completed. Relmada's late-stage development program for REL-1017 includes Reliance III, an ongoing monotherapy registrational Phase 3 trial.

In addition, Reliance I and Reliance II are two ongoing Phase 3 sister two-arm, placebo-controlled, pivotal studies evaluating REL-1017 as a potential adjunctive treatment for MDD. The Reliance development program also includes Reliance-OLS, the long-term open-label safety study that is enrolling rollover participants from all three pivotal studies, as well as de novo participants.