FDA Confirms Relmada Not Required To Conduct Two-Year Carcinogenicity Study To Support REL-1017 Data

Providing regulatory and development updates regarding its ongoing late-stage clinical program for REL-1017 in major depressive disorder (MDD) on Monday, biotechnology company Relmada Therapeutics, Inc. (RLMD) said it is actively enrolling patients in RELIANCE III, a Monotherapy Registrational Phase 3 Study.

RELIANCE III, the new ongoing monotherapy trial, aims to randomize 364 patients and it is expected to be completed in the second quarter of 2022.

Relmada also revealed that the FDA confirmed that, based on what is known at this time, Relmada will not be required to conduct a two-year carcinogenicity study of esmethadone (REL-1017), as sufficient pre-clinical safety data have been generated to date.

The FDA also confirmed that Relmada does not need to conduct a TQT cardiac study in humans to support cardiac safety in potential regulatory submissions for REL-1017, as the data provided so far and the data generated by the Phase 3 program will be adequate to evaluate the cardiac safety profile of REL-1017.

REL-1017, a new chemical entity (NCE) and novel NMDA receptor (NMDAR) channel blocker that preferentially targets hyperactive channels while maintaining physiological glutamatergic neurotransmission, is currently in late-stage development for the treatment of MDD.

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