Lipocine Announces Initiation Of A Phase 3 Trial For LPCN 1154 Which Is In Development For Treatment Of Postpartum Depression

Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company leveraging its proprietary technology platform to enable effective oral delivery of therapeutics, today announced the initiation of a Phase 3 trial for LPCN 1154 (oral brexanolone) which is in development for the treatment of postpartum depression (PPD).  

Based on observed comparable exposure of LPCN 1154 and the reference drug established in the pharmacokinetic (PK) 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. 

"We are excited to initiate this registration-enabling Phase 3 trial," said Mahesh Patel, CEO of Lipocine. "Importantly, based on FDA protocol feedback, patients will self-administer LPCN 1154 at home. We believe that LPCN 1154 has the potential to be the first line option for rapid symptom relief in women with PPD."