Lipocine initiates Phase 3 outpatient PPD trial of LPCN 1154; dosing expected Q2 2025

Lipocine Inc.

Initiation of randomized, blinded, placebo-controlled Phase 3 trial of LPCN 1154 for PPD; first patient dosing expected Q2 2025.
48-hour at-home self-administration regimen based on FDA protocol feedback.
Primary endpoint: change from baseline in HAM-D; secondary endpoints include MADRS and HAM-A.
Trial size powered based on observed effect of injectable brexanolone (Zulresso).

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