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Lipocine Announces LPCN 1154 Meets Bioequivalence with IV Brexanolone in Pivotal Study
Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC0-∞Ctrough criterion was metLPCN 1154 was well tolerated with no sedation or somnolence events
About this update from Lipocine Inc.
[{"type":"text","content":"Met standard bioequivalence (BE) criteria Cmax, AUC0-t, and AUC0-∞Ctrough criterion was metLPCN 1154 was well tolerated with no sedation or somnolence events observedOn track for NDA filing, targeted by end of Q4 2024SALT LAKE CITY, June 25, 2024 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive topline study results demonstrating bioequivalence of LPCN 1154 to IV brexanolone in an NDA enabling pivotal pharmacokinetic (PK) study. Lipocine is developing LPCN 1154, oral brexanolone, for the treatment of postpartum depression (PPD). The U.S. Food & Drug Administration (FDA) has agreed with Lipocine's proposal for a 505(b)(2) NDA filing based on a single pivotal PK bridging study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone. Intravenous brexanolone is approved based on evidence demonstrating efficacy and safety with two dosing regimens with different maximum infusion rates of either 60 µg/kg/hr (IV60) or 90 µg/kg/hr (IV90). Lipocine is targeting NDA submission by the end of the fourth quarter of 2024.\n\n \n \n \n \n \n \n\n \n\"I'm pleased with the positive outcome of this pivotal study which brings us a step closer to potentially offering a differentiated preferred treatment option for PPD patients in need,\" said Dr. Mahesh Patel, President and CEO of Lipocine. \"PPD is a serious and potentially life-threatening condition. LPCN 1154 is targeted to be a highly effective, oral, fast-acting and short duration treatment option. We believe a 48-hour oral dosing duration with fast onset of efficacy would be an important solution for patients and caregivers.\"\nPer published FDA bioequivalence guidance1, the criteria to establish bioequivalence are that Geometric Mean Ratios (GMR) and corresponding 90% confidence intervals (CIs) for AUC0-t, AUC0-∞, and Cmax (key measures of drug exposure) fall within 80% to 125% for test vs reference products.\nThe pivotal PK study was an open label, randomized, crossover study in 24 healthy postmenopausal women utilizing the \"to be marketed\" formulation and oral dosing regimen of LPCN 1154 and the commercial IV brexanolone formulation using the approved high dose infusion regimen (IV90). The primary objective of the st...