FDA grants Fast-Track status for Relmada’s major depressive disorder therapy
The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). In a Phase II trial, REL-1017 was found to offer quick and long-lasting antidepressant effects.
A new chemical entity and NMDA receptor (NMDAR) channel blocker, REL-1017 acts on hyperactive channels while preserving physiological glutamatergic neurotransmission.
Presently, the therapy is being analysed in late-stage studies.
The Reliance Clinical Research Program underway is analysing REL-1017’s potential as a quick-acting, oral, once-a-day antidepressant therapy.
A registrational Phase III trial, Reliance III, is analysing REL-1017 as a single agent. In addition, Reliance I and Reliance II are two Phase III sister placebo-controlled, two-arm trials analysing REL-1017 as a potential adjunctive MDD therapy.
The Reliance programme also comprises a long-term, open-label safety trial, Reliance-OLS, which is enrolling subjects who have completed the three trials, as well as de novo subjects.
According to findings from a Phase II trial, REL-1017 was found to offer quick and long-lasting antidepressant effects with statistically significant improvements versus placebo.
Furthermore, the favourable pharmacokinetic, safety and tolerability profile of REL-1017 was in line with data reported in prior Phase I trials.
Relmada Therapeutics chief scientific officer Paolo Manfredi said: “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 Fast-Track status from the regulatory agency aids in developing and accelerating the review of drugs for treating serious ailments, as well as meeting unmet medical needs.
August 10, 2022
