Lipocine receives updated regulatory guidance on LPCN 1154

Lipocine (LPCN) received revised regulatory guidance for LPCN 1154 which the company is developing for postpartum depression treatment. The company was scheduled to meet with the FDA in Q1 2025 to discuss the NDA submission package of LPCN 1154. Following the meeting, the company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and safety study of oral LPCN 1154 in the target population will be required for 505(b) NDA submission. Lipocine is planning next steps toward the execution of a phase 3 safety and efficacy study.