DT120 ODT (Lysergide (LSD)) - (Emerge)

Definium Therapeutics (Nasdaq: DFTX) announced that the FDA granted Breakthrough Therapy designation for DT120 (lysergide) ODT for major depressive disorder (MDD). The designation was supported by unmet need in MDD and results from the Phase 3 Emerge study, in which a single 100 µg dose of DT120 ODT produced a statistically significant 8.1-point placebo-adjusted improvement in MADRS total score at Week 6 (p<0.0001), with durability through Week 12.

This is the second FDA Breakthrough Therapy designation for the DT120 program, following an earlier designation for generalized anxiety disorder (GAD). The company said DT120 is also being developed for posttraumatic stress disorder (PTSD).

DT120 ODT is Definium’s orally disintegrating tartrate salt formulation of lysergide (LSD), using Catalent’s Zydis fast-dissolve technology. The release does not provide a regulatory filing date, action date, or other near-term catalyst beyond the new Breakthrough Therapy designation.