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Lipocine Announces Confirmation of Dosing Regimen for Pivotal Study of LPCN 1154
Positive clinical study results confirm 48-hour dosing regimen for the pivotal PK studyOn track for Q2-24 pivotal study topline results and planned Q4-24 NDA
About this update from Lipocine Inc.
[{"type":"text","content":"Positive clinical study results confirm 48-hour dosing regimen for the pivotal PK studyOn track for Q2-24 pivotal study topline results and planned Q4-24 NDA filing SALT LAKE CITY, Feb. 6, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders by leveraging its proprietary platform, today announced that results from a multi-dose clinical study have confirmed the LPCN 1154 48-hour dosing regimen for the upcoming NDA enabling pivotal pharmacokinetic (PK) study. LPCN 1154 is an oral neurosteroid being developed by Lipocine for the treatment of postpartum depression (PPD).\n\n \n \n \n \n \n \n\n \nPPD 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. Oral LPCN 1154 comprising a bioidentical neuroactive steroid with 48-hour outpatient dosing is targeted to provide rapid relief with robust efficacy. \nLipocine has previously confirmed with the U.S. Food and Drug Administration (FDA) acceptance of a proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone. Following a successful meeting with the FDA, Lipocine reached agreement on the use of exposure parameters and criteria to assess comparable exposure to IV infusion brexanolone.\nBased on positive results of the 2023 multi-arm crossover pilot PK study, Lipocine recently completed a single arm PK study (N=8) utilizing the \"to be marketed\" formulation and target dosing regimen. PK exposure results of the \"to be marketed\" scaled up formulation were consistent with the PK performance of pilot study clinical formulation. Furthermore, the exposure PK parameters observed in this study are comparable to those of IV infusion brexanolone administered per label instructions in the pilot study. There were no serious or severe adverse events observed in this single arm, multi-dose study, and a single report of asymptomatic, moderate decrease of oxygen saturation. Consistent with the goal of NDA submission by the end of the fourth quarter of 2024, the company anticipates top line results late in the sec...