Lipocine initiates Phase 3 trial for LPCN 1154

Lipocine (LPCN) announced the initiation of a Phase 3 trial for LPCN 1154 which is in development for the treatment of postpartum depression. Based on observed comparable exposure of LPCN 1154 and the reference drug established in the pharmacokinetic bridge study, the company is initiating a phase 3 safety and efficacy study with expected first patient dosed in the second quarter of 2025. This randomized, blinded, placebo controlled study is designed to evaluate safety and efficacy of LPCN 1154 in women with PPD. This outpatient trial is expected to support a global registration package for LPCN 1154 in PPD.