Core Insights - Orion Corporation's candidate ODM-105 (tasipimidine) did not meet the primary goal in the Phase 2 UNITAS study for treating insomnia, failing to show significant improvement in insomnia-related symptoms compared to placebo [1][2] - The study involved 153 adult patients and measured endpoints such as wake after sleep onset (WASO) and latency to persistent sleep (LPS) [3] - Despite the failure to meet primary goals, ODM-105 was generally safe and well tolerated, with detailed safety data yet to be finalized [1][4] Study Details - The UNITAS study was a Phase 2b randomized, triple-blind, and placebo-controlled trial [3] - Recruitment for the study was faster than expected, highlighting the significant unmet need for new insomnia treatments [2] - The company plans to focus on advancing other research and clinical assets following the study results [2]
Orion’s phase 2 study of ODM-105 in insomnia did not meet primary goal
Globenewswire·2025-09-30 10:00