Relmada Therapeutics, a biopharmaceutical company that specializes in developing treatments for central nervous system diseases, received approval from the U.S. Food and Drug Administration to advance a new therapy to clinical trials.
“The FDA’s acceptance of our application for d-Methadone represents a very significant milestone for Relmada and further validation of our efforts to develop innovative therapies with the potential to address some of the most challenging unmet needs in the treatment of depression,” Richard Mangano, chief scientific officer at Relmada, said.
d-Methadone, a drug that is designed to help patients suffering with treatment-resistant depression, is now authorized to move ahead to the developmental stage.
“Building on the findings from our single- and multiple-ascending dose studies that demonstrated a targeted dose range without the side effects associated with racemic methadone and ketamine, d-Methadone has the potential to represent a paradigm shift in the treatment of major depressive disorder in the year ahead,” Mangano said.
FDA approves d-Methadone for clinical trials
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