Lipocine(US:LPCN) Prnewswire·2026-01-12 13:00Core Viewpoint - Lipocine Inc. has completed a scheduled independent Data Safety Monitoring Board (DSMB) review of its Phase 3 clinical trial for LPCN 1154, which is aimed at treating postpartum depression (PPD), and the trial will continue without modifications [1][2]. Group 1: Clinical Trial Details - The DSMB's recommendation was based on safety data from 82 randomized participants, with 74 completing dosing, and no serious adverse events or treatment discontinuations reported [2][7]. - The study is no longer screening new participants but continues to enroll eligible participants, with topline safety and efficacy results expected in early Q2 2026 [3][4]. - The Phase 3 study is a pivotal, randomized, double-blind trial comparing LPCN 1154 to placebo in women aged 15 and older diagnosed with severe PPD, conducted entirely in an outpatient setting [4][5]. Group 2: Product Overview - LPCN 1154 is an oral formulation of brexanolone designed for rapid relief of PPD, potentially becoming a first-line treatment option for women, with no significant risk of adverse reactions to breastfed infants [5][6]. - The product aims to address the unmet medical needs in PPD treatment, as traditional antidepressants have slow onset and side effects [6]. Group 3: Company Background - Lipocine is a biopharmaceutical company focused on developing innovative products with effective oral delivery, targeting large markets with significant unmet medical needs [8][9]. - The company's development pipeline includes several candidates for various conditions, including LPCN 2201 for major depressive disorder and LPCN 2101 for epilepsy, among others [9].