Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, announced on Monday that it has completed enrolment and dosing of first cohort of subjects in pivotal pharmacokinetic (PK) study aimed at supporting a New Drug Application (NDA) for LPCN 1154.

The product is an oral brexanolone and is being developed by Lipocine for the treatment of postpartum depression (PPD).

The pivotal PK study, an open label, randomised, crossover study, is being conducted in 24 healthy postmenopausal women using the 'to be marketed' formulation of LPCN 1154 and dosing regimen. The study's primary objective is to compare the pharmacokinetics of a multi-dose regimen of oral LPCN 1154 to IV infusion brexanolone administered per label instructions. During the two treatment visits, each participant is to receive the oral and IV brexanolone regimens in a randomised, crossover manner. Safety and tolerability of the multidose regimen of LPCN 1154 will also be evaluated.

Consistent with the goal of NDA submission by the end of the fourth quarter of 2024, the company anticipates topline results from this crossover pivotal study late in the second quarter of 2024.