Lipocine Reports Topline Safety and Efficacy Results for LPCN 1154 in Patients with Postpartum Depression
Lipocine Inc. announced that its Phase 3 trial for LPCN 1154 (oral brexanolone) in postpartum depression (PPD) did not meet its primary endpoint in the overall patient population. However, a post hoc analysis of participants with a history of psychiatric conditions showed nominal statistically significant and clinically meaningful reductions in HAM-D scores compared to placebo. The company plans to evaluate all available options and has applied for breakthrough therapy and fast track designations for LPCN 1154 in this subset of patients.