FDA Grants Fast Track Designation to Novel MDD Monotherapy

The US Food and Drug Administration (FDA) granted a fast track designation to Relmada Therapeutics’ REL-1017, a novel NMDA receptor (NMDAR) channel blocker, as a monotherapy for the treatment of major depressive disorder (MDD). 

In a phase 2 trial, REL-1017 showed “rapid, robust, and sustained antidepressant effects with significant improvements compared to placebo,” the late-stage biotechnology company said in a news release. REL-1017 targets hyperactive channels while maintaining physiological glutamatergic neurotransmission.

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A fast track designation process facilitates the development and expedites the review of drugs to treat serious conditions with high unmet medical needs. To receive this designation, a drug must show an advantage over available therapy.

“This designation further supports the potential of REL-1017 as a paradigm-shifting, novel standalone 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,” said Paolo Manfredi, chief scientific officer at Relmada Therapeutics, Coral Gables, Florida.

An ongoing monotherapy registrational phase 3 trial that includes 2 placebo-controlled, pivotal studies are part of the company’s late-stage development program for REL-1017. The program also includes a long-term open-label safety study enrolling rollover participants from all 3 pivotal studies and de novo participants.

References

Relmada Therapeutics receives FDA fast track designation for REL-1017 as a monotherapy for the treatment of major depressive disorder. News release. Relmada Therapeutics. August 9, 2022. Accessed August 11, 2022.

Fast track. US Food and Drug Administration. Updated January 4, 2018. Accessed August 11, 2022.