Lipocine says first patient dosed in LPCN 1154 study

Lipocine announced that the first participant has been dosed in a pilot clinical bridge study of LPCN 1154 and approved injectable brexanolone. The U.S. FDA has agreed with Lipocine’s proposal for establishing the efficacy and safety of LPCN 1154 in women with PPD through a clinical 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.