Supernus Pharmaceuticals’ Depression Drug SPN-820 Fails to Meet Primary Endpoint in Phase 2b Trial

Supernus Pharmaceuticals' drug candidate SPN-820 for treatment-resistant depression (TRD) failed to meet its primary endpoint in a Phase 2b clinical trial1 2.

The study did not demonstrate a statistically significant improvement in depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo1 4.

The trial involved approximately 250 adult patients with TRD across 40 clinical sites, with treatment lasting four weeks followed by a week of blinded placebo-washout1 4.

SPN-820 showed a good safety profile, with few adverse events reported, consistent with previous clinical trials1 4.

Following the announcement, Supernus Pharmaceuticals' stock price dropped by approximately 20% in after-hours trading2 3.

The company plans to continue analyzing the data and discuss the future of the program with its development partner, Navitor Pharmaceuticals1 2.

This setback affects Supernus' pipeline in the central nervous system (CNS) disease area, where the company focuses on developing and commercializing treatments1 4.

The high placebo response in neuropsychiatric drug trials remains a significant challenge in the field, potentially contributing to the study's failure5.