Lipocine announced that dosing of subjects has been completed in the pivotal pharmacokinetic study designed to support a New Drug Application for LPCN 1154, being developed as a treatment of postpartum depression. Lipocine anticipates topline results late in Q2, with the goal of NDA submission by the end of Q4. Lipocine has confirmed with the FDA acceptance of a proposal for a 505(b) NDA filing enabled by a single pivotal PK study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone.
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