Lipocine has dosed the first patient in a Phase III trial assessing LPCN 1154 (oral brexanolone) for the treatment of postpartum depression (PPD).
The outpatient, placebo-controlled Brexanolone Lifting Outcomes of Moms (BLOOM) trial (NCT07822321) will assess the therapy as a 48-hour oral course designed for at-home administration.
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It is expected to enrol around 120 patients, with topline findings anticipated in the second half of 2027.
BLOOM will examine the primary efficacy endpoint through change from baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score at 60 hours after treatment begins.
Lipocine aims to use the resulting safety and efficacy data to complement an existing clinical package to the US Food and Drug Administration (FDA) for a potential new drug application (NDA) under the 505(b)(2) pathway.
Lipocine president and CEO Dr Mahesh Patel said: “Our goal is to develop a treatment that provides rapid symptom relief through a 48-hour oral course taken at home.
“We believe the BLOOM Phase III study is designed to promote study enrolments that are representative of the actual patient population of postpartum depression and provide confidence in data quality.”
The new trial integrates adjustments following an earlier Phase III study, which did not meet its primary endpoint in the full analysis set, though post hoc findings and safety results supported continued development.
Feedback from a meeting with the FDA confirmed the necessity of a positive, well-controlled Phase III trial, while indicating that the remainder of the 505(b)(2) application package appeared complete.
To mitigate placebo response, BLOOM incorporates centralised rating for screening, fewer rating scales, decreased patient interaction with site staff, and standardised participant education.
Operational controls also include third-party site selection, participation by academic centres, geographic diversity, participant limits per site, and prespecified sensitivity analyses covering outlier sites and pharmacokinetic data.
LPCN 1154 is an unapproved oral formulation of brexanolone that is a chemical match to allopregnanolone, a neuroactive steroid modulating gamma-aminobutyric acid type A (GABA-A) receptor.
PPD is a serious condition that can cause persistent sadness, anxiety, daily impairment, and thoughts of self-harm.
