The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ REL-1017, the company’s novel NMDA receptor (NMDAR) channel blocker, as a monotherapy for the treatment major depressive disorder (MDD).
“The receipt of Fast Track Designation represents a significant milestone for our promising late-stage REL-1017 development program,” said Paolo Manfredi, chief scientific officer.
“This designation further supports the potential of REL-1017 as a paradigm shifting novel stand-alone treatment for MDD and highlights the significant unmet medical need in a therapeutic area where little has changed over the last several decades: available treatments remain inadequate for the majority of patients with MDD. We thank the FDA for this designation and we will continue to work closely with the Agency to bring this much needed potential new therapy to patients as expeditiously as possible.”
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.