Posted by Michael Wonder on 14 Apr 2017
Relmada announces FDA fast track designation for d-methadone for adjunctive treatment of major depressive disorder
13 April 2017 - Relmada Therapeutics today announced that the U.S. FDA has granted fast track designation for d-Methadone (REL-1017, dextromethadone), the company's novel N-methyl-D-aspartate receptor antagonist in development for the adjunctive treatment of major depressive disorder.
Relmada is planning to advance the development program for REL-1017 to a phase 2a randomised, 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.
