Lipocine Highlights Promising Interim Safety Profile in Phase 3 Trial of LPCN 1154 in Postpartum Depression (PPD)

Core Insights - The Drug Safety Monitoring Board (DSMB) has reviewed the ongoing Phase 3 clinical trial of LPCN 1154 and has recommended that the study continue as planned [1] - More than half of the planned participants have completed dosing without any reported dose reductions, discontinuations, drug-related serious adverse events (SAEs), loss of consciousness, or excessive sedation [1] - Topline results are expected to be available in the second quarter of 2026 [1] Company Summary - Lipocine Inc. is a biopharmaceutical company focused on developing innovative products with effective oral delivery using its proprietary technology platform [1] - The ongoing Phase 3 clinical trial is evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of postpartum depression (PPD) [1] - The DSMB review was conducted after approximately one-third of the planned 80 participants (n=30) completed at least the day seven follow-up visit [1]