Lipocine completes Phase 3 enrollment for oral brexanolone in postpartum depression; topline data due Q2 2026

Lipocine Inc.

90 patients randomized in double-blind, placebo-controlled Phase 3 trial of LPCN 1154 (oral brexanolone) for PPD.
Safety profile favorable: no discontinuations, excessive sedation, loss of consciousness, or drug-related SAEs.
Outpatient setting, no medical monitoring required; study incorporates FDA feedback.
Topline efficacy and safety results expected early Q2 2026; NDA submission planned for 2026.
LPCN 1154 could become first-line treatment for severe PPD, including elevated suicide risk.

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