Lipocine Confirms Dosing Regimen for Pivotal Study of LPCN 1154 for postpartum depression

 

• Positive clinical study results confirm 48-hour dosing regimen for the pivotal PK study
• On track for Q2-24 pivotal study topline results and planned Q4-24 NDA filing 

 Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that results from a multi-dose clinical study have confirmed the LPCN 1154 48-hour dosing regimen for the upcoming NDA enabling pivotal pharmacokinetic (PK) study. LPCN 1154 is an oral neurosteroid being developed by Lipocine for the treatment of postpartum depression (PPD).

Consistent with the goal of NDA submission by the end of the fourth quarter of 2024, the company anticipates top line results late in the second quarter of 2024 from the crossover pivotal study of LPCN 1154 with the reference product IV brexanolone.

https://www.biospace.com/article/releases/lipocine-announces-confirmation-of-dosing-regimen-for-pivotal-study-of-lpcn-1154/