Relmada Secures FDA Fast Track Status For Depressive Disorder Candidate

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Relmada Therapeutics’ RLMD lead asset REL-1017 as a monotherapy for the treatment major depressive disorder (MDD).

REL-1017 is being investigated in an on-going monotherapy Phase 3 clinical trial under Reliance III study in patients with major depressive disorder (MDD). REL-1017 is also being evaluated in the ongoing Reliance I and Reliance II studies as a potential adjunctive treatment for MDD.

Paolo Manfredi, Chief Scientific Officer, commented: "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.”

FDA Fast Track Designation is intended to expedite the development and review of new drugs to treat serious medical conditions that fill unmet medical needs.

Price Action : Relmada shares are trading around 2 percent down at $26.96 on Tuesday at the time of publication.