Lipocine Announces Completion of Dosing in Pivotal Study of Postpartum Depression Candidate, LPCN 1154

Pivotal study design aligned with FDA on streamlined pathway to NDA submission goal in 2024

Topline results anticipated late in 2Q 2024

SALT LAKE CITY, May 1, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company, today announced that dosing of subjects has been completed in the pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed as a treatment of postpartum depression (PPD).  Lipocine anticipates topline results late in the second quarter of 2024, with the goal of NDA submission by the end of the fourth quarter of 2024.

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