Lipocine has dosed the first subject in a pilot clinical bridge study of depression candidate, LPCN 1154 (oral brexanolone), and approved injectable brexanolone. 

LPCN 1154, which is an oral formulation of brexanolone, is currently under development for use in quick relief of postpartum depression (PPD).

PPD can occur either during the course of pregnancy or within four weeks of delivery.

Lipocine noted that the US Food and Drug Administration (FDA) has approved its plan to confirm the efficacy and safety of LPCN 1154 in women with PPD via a clinical (pharmacokinetic) bridge to an approved IV infusion of brexanolone through a 505(b)(2) NDA application. 

The firm intends to carry out a pivotal trial in support of the NDA application pending results from the pilot clinical bridge trial.

The open-label, randomised, partial crossover study aims to enrol 12 subjects in total.

It is currently being carried out at a single centre in the US, with plans to unveil topline results in the first half of this year.

The trial’s primary objective is to compare the multidose regimen exposures of orally administered LPCN 1154 and a non-stop IV infusion of brexanolone in healthy post-menopausal women, as well as select the dose for the pivotal study.

Its secondary objective includes the analysis of the safety and tolerability of multidose regimens of oral LPCN 1154.

Lipocine president and CEO Dr Mahesh Patel said: “We believe that, if approved, LPCN 1154, comprising a bioidentical active, has the potential to be a differentiated treatment for PPD, providing a convenient oral treatment option for administration in outpatient settings that would be less burdensome on patients, caregivers, and providers.”