d-Methadone for Adjunctive Treatment of Major Depressive Disorder Fast Tracked by FDA

Relmada Therapeutics, Inc., a clinical-stage company developing novel therapies for the treatment of central nervous system diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for d-Methadone (REL-1017 dextromethadone), the company's novel N-methyl-D-aspartate (NMDA) receptor antagonist in development for the adjunctive treatment of major depressive disorder.

Fast Track designation facilitates the development and expedites the review of drugs to treat serious conditions and fill an unmet medical need. The purpose, according to the FDA, is to get new drugs to the patient earlier. Drugs that receive Fast Track designation may be eligible for more frequent meetings and written communications with the FDA, accelerated review and priority approval, and rolling New Drug Application review.

"Treatment of depression continues to be a significant challenge in healthcare affecting millions of patients around the world," said Richard Mangano, Ph.D., chief scientific officer of Relmada. "The designation of Fast Track status by the FDA is further validation of the potential for d-Methadone to represent a major advance in treatment that can help patients with inadequate response to the current standard of care. We look forward to working with the FDA to advance the development program for d-Methadone and an expedited regulatory process."

Relmada is planning to advance the development program for REL-1017 to a phase 2a randomized, double-blind, placebo-controlled study in patients with major depressive disorder. The study will assess changes in depressive symptoms as well as the safety, tolerability and pharmacokinetics of two dose levels of REL-1017 as rapid acting adjunctive treatment in patients during a seven-day dosing period and 14-day observation period.