Shots:
- Definium Therapeutics announced that the US FDA granted BTD to DT120 (lysergide) orally disintegrating tablet (ODT) for the treatment of major depressive disorder (MDD), following positive P-III results
- In the P-III Emerge study, a single 100 µg dose of DT120 ODT demonstrated an 8.1-point PBO-adjusted improvement in MADRS total score at wk. 6 (p<0.0001), with durable efficacy reported through wk. 12
- The designation marks the second FDA BTD for DT120, following its designation in generalized anxiety disorder (GAD); Definium is also developing DT120 for posttraumatic stress disorder (PTSD)
Ref: Definium | Image: Definium | Press Release
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