Lipocine: LPCN 1154 Meets Standard Bioequivalence Criteria In Pivotal Pharmacokinetic Study

(RTTNews) - Lipocine (LPCN) reported positive topline study results showing bioequivalence of LPCN 1154 to IV brexanolone in an NDA enabling pivotal pharmacokinetic study. The pivotal PK study was an open label, randomized, crossover study in 24 healthy postmenopausal women. The company is targeting NDA submission by the end of the fourth quarter of 2024.

LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of postpartum depression. Brexanolone is a bioidentical to naturally occurring neuroactive steroid, allopregnanolone.

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