Lipocine Inc. announced that study enrollment is complete and the first cohort of subjects has been dosed in pivotal pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154. LPCN 1154, oral brexanolone, is being developed by Lipocine for the treatment of postpartum depression (PPD). The pivotal PK study is an open label, randomized, crossover study in 24 healthy postmenopausal women utilizing the "to be marketed" formulation of LPCN 1154 and dosing regimen.

The primary objective of the study 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 will receive the oral and IV brexanolone regimens in a randomized, 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. PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting for up to 12 months after childbirth. There is an unmet need for an oral fast-acting product with an improved efficacy and safety profile to treat PPD.

Oral LPCN 1154, comprising a bioidentical neuroactive steroid with 48-hour outpatient dosing, is being developed to provide rapid relief with robust efficacy. Recent reports suggest that the market size for PPD is larger than previously estimated. Approximately 500,000 women are affected by PPD annually in the United States and, according to the CDC, an estimated 175,000 women suffer from moderate to severe PPD.

Increasing awareness of PPD among physicians and patients is expected to result in higher diagnosis rates and greater numbers of patients seeking treatment. Lipocine has confirmed with the U.S. Food and Drug Administration (FDA) acceptance of a proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone.