Lipocine Completes Dosing in Pivotal Postpartum Depression Study

Shares in Lipocine Inc. (Nasdaq: LPCN) rose slightly to reach $4.63 after the company announced that it had completed dosing of subjects in its pivotal clinical study of LPCN 1154 (oral brexanolone) as a treatment for postpartum depression (PPD). Lipocine’s pharmacokinetic (PK) study designed to support a New Drug Application (NDA) for LPCN 1154.

PPD is a severe, long-lasting form of depression that affects approximately 500,000 women in the US each year. Symptoms can persist for up to 12 months after childbirth, and there is an unmet need for an oral fast-acting product with an improved efficacy and safety profile to treat PPD.

Commenting on the study, Dr. Mahesh Patel, President and CEO of Lipocine, said, “We are pleased to complete dosing of participants in this NDA enabling study of LPCN 1154. We look forward to reporting topline results from this study late in the second quarter of 2024.”

Lipocine anticipates topline results late in the second quarter of 2024, with the goal of NDA submission by the end of the year. The FDA has agreed to accept a proposal for a 505(b)(2) NDA filing enabled by a single pivotal PK study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone.

About Lipocine

Lipocine is a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery to develop differentiated products for CNS disorders. Lipocine has drug candidates in development as well as drug candidates for which we are exploring partnerships. Our drug candidates represent enablement of differentiated, patient friendly oral delivery options for favorable benefit to risk profile which target large addressable markets with significant unmet medical needs. For more information