Lipocine confirms dosing regimen for pivotal study of LPCN 1154

Lipocine 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 study. LPCN 1154 is an oral neurosteroid being developed by Lipocine for the treatment of postpartum depression. Lipocine has previously confirmed with the FDA acceptance of a proposal for a 505(b) 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. Consistent with the goal of NDA submission by the end of Q4, the company anticipates top line results late in Q2 from the crossover pivotal study of LPCN 1154 with the reference product IV brexanolone.