Lipocine(US:LPCN) Prnewswireยท2025-09-30 12:00Core Insights - Lipocine Inc. is progressing with its pivotal Phase 3 clinical trial for LPCN 1154, an oral formulation of brexanolone aimed at treating postpartum depression (PPD), with one-third of the planned patients already randomized and topline results expected in Q2 2026 [1][3][2] Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing innovative products with effective oral delivery using its proprietary technology platform [7][8] - The company has multiple drug candidates in development, including LPCN 1154 for PPD, LPCN 2101 for epilepsy, and LPCN 2203 for essential tremor, among others [9] Clinical Trial Details - The Phase 3 trial is a randomized, double-blind study comparing LPCN 1154 to placebo in women aged 15 and older diagnosed with severe PPD, conducted entirely in an outpatient setting without the need for medical monitoring [3][6] - A Data Safety Monitoring Board (DSMB) meeting is scheduled for Q4 2025 to review safety data from the one-third of patients randomized [2] Product Characteristics - LPCN 1154 is designed for a 48-hour dosing schedule, offering potential rapid and meaningful clinical benefits for women suffering from PPD, with no significant risk of adverse reactions to breastfed infants [5][3] - The product aims to address the unmet needs in PPD treatment, as traditional antidepressants have slow onset and various side effects [6] Market Context - Postpartum depression is a significant issue, with estimates suggesting that 20-40% of obstetricians believe their patients may suffer from it, highlighting a substantial market opportunity for effective treatments [6]