Definium Therapeutics Gains FDA Breakthrough Therapy Designation for DT120

Definium Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to DT120 orally disintegrating tablets (ODT), the company’s investigational lysergide-based treatment for major depressive disorder (MDD).

The regulatory designation follows findings from the Phase 3 Emerge study. 

According to the company, participants who received a single 100 µg dose recorded an 8.1-point greater reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) scores than those receiving placebo at Week 6.
 
The result was statistically significant, with p<0.0001, and the reported treatment effect continued through Week 12.

DT120 has now received two FDA Breakthrough Therapy designations. The earlier designation was granted for its development in generalised anxiety disorder (GAD).

DT120 ODT is a pharmaceutical formulation of lysergide incorporating Catalent’s Zydis® orally disintegrating tablet technology. 

Definium is developing the formulation for MDD, GAD and post-traumatic stress disorder (PTSD), and is assessing its potential in other brain health conditions.

MDD remains a major treatment challenge in the US, affecting more than 21 million adults each year. 

Existing therapies do not lead to remission for many patients, creating a need for additional treatment approaches.

The FDA Breakthrough Therapy programme is intended to facilitate the development and review of medicines for serious conditions when early clinical evidence suggests the potential for substantial improvement over available treatment options.