Lipocine Advances Postpartum Depression Candidate
Lipocine Inc. (Nasdaq: LPCN) has confirmed the dosing regimen for its upcoming New Drug Application (NDA)-enabling pivotal pharmacokinetic (PK) study of LPCN 1154, an oral neurosteroid being developed for the treatment of postpartum depression (PPD).
The company is on track to release pivotal study topline results from the pivotal study in Q2 2024 and plans to file an NDA in Q4 2024.
Dr. Mahesh Patel, President and CEO of Lipocine, commented, “LPCN 1154 is targeted to be a highly effective, oral, fast-acting and short duration treatment option for PPD, a serious and potentially life-threatening condition. We believe a 48-hour oral dosing duration will be important for patients and caregivers. If approved, LPCN 1154 has the potential to be a differentiated preferred treatment option for PPD.”
Highlights
LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD.
PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery, with symptoms persisting for up to 12 months after childbirth. There is an unmet need for an oral fast-acting product with an improved efficacy and safety profile to treat PPD.
The company’s studies have presented no significant risk of adverse reactions to breastfed infants from exposure to 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 partnering. 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.
