Lipocine’s LPCN 1154 meets bioequivalence with IV Brexanolone in pivotal study

Lipocine announced positive topline study results demonstrating bioequivalence of LPCN 1154 to IV brexanolone in an NDA enabling pivotal pharmacokinetic study. Lipocine is developing LPCN 1154, oral brexanolone, for the treatment of postpartum depression, or PPD. The 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. Lipocine is targeting NDA submission by the end of Q4. The study was an open label, 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. LPCN 1154 and IV90 brexanolone were bioequivalent based on GMRs and 90% CIs for Cmax, AUC0-, and AUC0-t meeting established criteria. Ctrough of LPCN 1154 geometric mean was higher than the trough of IV brexanolone. LPCN 1154 treatment was well tolerated with no sedation nor somnolence events observed.