Supernus’ SPN-820 Shows Rapid Symptom Improvement in Major Depressive Disorder

Clinical Trial Success:
Supernus Pharmaceuticals announced that its investigational drug SPN-820 demonstrated a "swift and significant" impact in a Phase IIa clinical trial targeting adults with major depressive disorder (MDD).

Rapid Symptom Improvement:
The drug showed a clinically relevant enhancement of -6.1 on the Hamilton Depression Rating Scale-6 items (HAM-D6) at two hours, improving to -9.6 by day 10.

Suicidal Ideation Reduction:
Suicidal ideation decreased by 80%, from 12.5% at baseline to 2.6% on day ten.

Tolerability:
SPN-820 was generally well-tolerated, with adverse events including headaches, nausea, and drowsiness.

Mechanism of Action:
SPN-820 is a first-in-class, oral small molecule designed to enhance synaptic function in the brain by activating the mechanistic target of rapamycin complex 1 (mTORC1) pathway.

Ongoing Phase IIb Trial:
A Phase IIb trial (NCT05066672) investigating SPN-820 in approximately 227 adult patients with treatment-resistant depression is currently underway, with preliminary results expected in the first half of 2025.