Lipocine Inc. announced that the first participant has been dosed in a pilot clinical bridge study of LPCN 1154 (oral brexanolone) and approved injectable brexanolone. The U.S. Food and Drug Administration (FDA) has agreed with Lipocine's proposal for establishing the efficacy and safety of LPCN 1154 in women with PPD through a clinical (pharmacokinetic) bridge to an approved IV infusion of brexanolone via a 505(b)(2) NDA filing. Lipocine plans to conduct a pivotal study designed to support NDA filing pending results from the pilot clinical bridge study.

LPCN 1154 is targeted to be a rapid onset “at home” oral treatment option for PPD with improved treatment access and ease of use without disrupting bonding/breast feeding interactions compared to the current, approved PPD standard of care with its significant limitations. The pilot clinical bridge study is an open label, randomized, partial crossover study. The primary objective of the study is to compare the exposures of multidose regimens of orally administered LPCN 1154 and a continuous IV infusion of brexanolone in healthy postmenopausal women and to inform the dose selection for the pivotal study.

The secondary objective is to evaluate the safety and tolerability of multidose regimens of oral LPCN 1154. The study is expected to enroll a total of 12 participants and is being conducted at a single center in the US. Results are expected in the first half of 2023.