Lipocine's PPD Phase 3 Study (LPCN 1154) Hits 80% Enrollment Milestone

Core Viewpoint - Lipocine Inc. is progressing in its Phase 3 clinical trial for LPCN 1154, an oral treatment for postpartum depression (PPD), with 80% enrollment completed and positive recommendations from the Data Safety Monitoring Board [1][2][7] Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing innovative products with effective oral delivery using its proprietary technology platform [5] - The company has multiple drug candidates in development targeting significant unmet medical needs, including LPCN 1154 for PPD and others for major depressive disorder, epilepsy, and obesity management [6] Phase 3 Study Details - 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 [2] - The trial is conducted entirely in an outpatient setting, following feedback from the U.S. FDA, and does not require medical monitoring by healthcare providers [2] - Data from this trial is expected to support a 505(b)(2) NDA submission for LPCN 1154 in 2026 [2] LPCN 1154 Characteristics - LPCN 1154 is an oral formulation of brexanolone aimed at providing rapid relief for PPD, potentially becoming a first-line treatment option [3] - The formulation is designed to minimize risks for breastfeeding infants while addressing acute needs in patients with elevated suicide risk [3] Postpartum Depression Context - PPD is a major depressive disorder that can occur during pregnancy or within four weeks post-delivery, with symptoms including sadness, fatigue, and suicidal thoughts [4] - A survey indicated that obstetricians estimate 20-40% of their patients may suffer from PPD, highlighting a significant unmet medical need in this population [4]