LPCN - Lipocine stock dips after bridging study data of LPCN 1154 for postpartum depression

2023-05-16 09:47:57 ET

Lipocine ( NASDAQ: LPCN ) stock fell ~6% on Tuesday after reporting data from a pilot pharmacokinetic (PK) bridge study of LPCN 1154 (oral brexanolone), versus IV brexanolone for postpartum depression (PPD).

The study enrolled 12 people and evaluated different dosing regimens of LPCN 1154 (oral brexanolone) versus the IV dosing regimens.

The company said DR 1 regimen resulted in comparable brexanolone exposure (Cmax and AUC?) to IV brexanolone 60 µg/kg/hr regimen.

The DR 2 regimen led to exposure levels (Cmax and AUC?) within the two clinically-effective IV brexanolone dosing regimens (60 µg/kg/hr and 90 µg/kg/hr), according to the company.

Lipocine added that LPCN 1154 was well-tolerated with no hypoxia or sedation-related adverse events.

The dosing regimen has been identified for a confirmatory PK study, according to the company.

Lipocine said that the U.S. Food and Drug Administration (FDA) agreed with Lipocine's proposal for establishing efficacy of LPCN 1154 in women with PPD via a PK bridge to the approved IV infusion of brexanolone through anticipated NDA filing.

The company plans to start a single confirmatory PK study in H2 2023 to establish efficacy, pending FDA feedback.

PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery.

For further details see: