Lipocine(LPCN) Prnewswire·2025-03-26 12:00Core Viewpoint - Lipocine Inc. has initiated a Phase 3 trial for LPCN 1154, an oral formulation of brexanolone, aimed at treating postpartum depression (PPD) [1][2][3] Company Overview - Lipocine Inc. is a biopharmaceutical company focused on developing effective oral delivery systems for therapeutics [7] - The company is exploring partnerships for various drug candidates, including LPCN 1154 for PPD and others targeting conditions like epilepsy and obesity [9] Clinical Trial Details - The Phase 3 trial for LPCN 1154 is a randomized, blinded, placebo-controlled study designed to evaluate safety and efficacy in women aged 15 and older diagnosed with severe PPD [3][4] - The trial will involve a 48-hour dosing period, with the first patient expected to be dosed in Q2 2025 [2][8] - Primary endpoint includes the change from baseline in the Hamilton Depression Rating Scale (HAM-D), with secondary endpoints assessing anxiety symptoms and safety measures [4] Product Information - LPCN 1154 is designed for rapid relief of PPD and is a bioidentical formulation of the neuroactive steroid allopregnanolone [5] - The product aims to address significant unmet medical needs in PPD treatment, particularly for patients with acute symptoms and elevated suicide risk [5][6] Market Context - Postpartum depression is a major depressive disorder affecting 20-40% of obstetric patients, with 64% of women with PPD also experiencing anxiety symptoms [6] - Traditional antidepressants are not approved for PPD and have slow onset and side effects, highlighting the need for effective treatments like LPCN 1154 [6]