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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).
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. Oral LPCN 1154 comprising a bioidentical neuroactive steroid with 48-hour outpatient dosing is targeted to provide rapid relief with robust efficacy.
Lipocine 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.
Based 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 second quarter of 2024 from the crossover pivotal study of LPCN 1154 with the reference product IV brexanolone.
"We believe these results support the design of the planned NDA enabling pivotal study," said Dr. Mahesh Patel, President and CEO of Lipocine. "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."
About LPCN 1154
LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of postpartum depression (PPD). Brexanolone is a bioidentical to naturally occurring neuro active steroid, allopregnanolone, a positive allosteric modulator of y-aminobutyric acid (GABA) receptor. LPCN 1154 is expected to have characteristics that could be particularly appealing to patients with severe PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants from exposure to brexanolone.
Posted In: LPCN
