(RTTNews) - Lipocine Inc. (LPCN), a biopharmaceutical company specializing in oral drug delivery, has commenced a Phase 3 trial for LPCN 1154 (oral brexanolone), an investigational treatment for postpartum depression (PPD).
The decision follows pharmacokinetic (PK) studies demonstrating comparable drug exposure between LPCN 1154 and its reference drug.
The randomized, placebo-controlled trial will evaluate safety and efficacy in women with severe PPD, with the first patient expected to be dosed in Q2 2025. Designed as an outpatient study, the trial aims to support global regulatory approval for LPCN 1154.
The trial will include women aged 15 and older diagnosed with severe postpartum depression (PPD), who will receive either LPCN 1154 or a placebo over a 48-hour treatment period, mirroring the dosing regimen from Lipocine's PK bridge study. The primary endpoint will assess changes in Hamilton Depression Rating Scale (HAM-D) scores to measure depression severity.
Secondary endpoints will evaluate changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and Hamilton Anxiety Rating Scale (HAM-A) scores, along with safety and tolerability outcomes. The trial size is based on treatment effects observed with FDA-approved injectable brexanolone.
LPCN 1154 is an oral formulation of brexanolone, designed for rapid symptom relief in PPD patients, including those at high suicide risk. It is a bioidentical neuroactive steroid (allopregnanolone) that modulates the GABA receptor, a key factor in depression. Unlike traditional antidepressants, it is expected to provide faster onset of action and minimal risk to breastfed infants.
PPD is a major depressive disorder occurring during pregnancy or within four weeks post-delivery, with symptoms lasting up to a year. It is characterized by sadness, mood disturbances, sleep issues, cognitive difficulties, and suicidal thoughts.
A 2024 survey found that 20-40% of obstetric patients may experience PPD, with 64% also reporting anxiety symptoms. While antidepressants are commonly prescribed, they have slow onset, side effects, and limited efficacy for long-term remission. LPCN 1154 aims to address these gaps by offering a rapid-acting, effective oral therapy for severe PPD cases.
LPCN is currently trading at $3.6359 or 2.13% higher on the Nasdaq Capital Market.
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