FDA requires Phase 3 efficacy/safety study for Lipocine's LPCN 1154 in PPD

Lipocine Inc.

FDA advised that an efficacy and safety study in target population is needed for 505(b)(2) NDA submission, beyond prior PK bridge data.
Lipocine is now planning a Phase 3 safety and efficacy study for oral LPCN 1154 (brexanolone) for postpartum depression.
CEO stated study could support product labeling, exclusivity for 48-hour oral treatment, and also investigate anxiety disorders.
Previous expectations were to discuss NDA package in Q1 2025; new guidance adds clinical trial requirement.

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