Research & Development
Relmada Therapeutics REL-1017 receives US FDA Fast Track designation to treat major depressive disorder
10 August 2022 -

Relmada Therapeutics, Inc. (Nasdaq: RLMD), a US-based, late-stage biotechnology company, announced on Tuesday that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for its REL-1017, the company's novel NMDA receptor (NMDAR) channel blocker, as a monotherapy for the treatment of major depressive disorder (MDD).

Paolo Manfredi, chief scientific officer, said, 'The receipt of Fast Track Designation represents a significant milestone for our promising late-stage REL-1017 development program. 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 product is a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that is aimed at hyperactive channels while maintaining physiological glutamatergic neurotransmission and is presently in late-stage development to treat major depressive disorder (MDD).

The ongoing Reliance Clinical Research Program is aimed at assessing the potential for REL-1017 as a rapid-acting, oral, once-daily antidepressant treatment. During a Phase two trial, the product showcased rapid, robust, and sustained antidepressant impacts with statistically significant improvements compared to placebo. The Phase two study also demonstrated a favourable pharmacokinetic, safety, and tolerability profile for the product, consistent with outcomes observed in earlier completed Phase one studies.