11:15 AM EDT, 03/25/2024 (MT Newswires) -- Lipocine ( LPCN ) said Monday that it has completed enrollment and dosed the first group of participants in the pivotal pharmacokinetic study of drug candidate LPCN 1154, or oral brexanolone, to treat postpartum depression.

The study, an open-label crossover trial involving 24 healthy postmenopausal women, aims to compare the pharmacokinetics of a multi-dose regimen of oral brexanolone with IV infusion brexanolone, according to Lipocine ( LPCN ).

The company said it expects to release topline results in late Q2 so it can submit its new drug application by the end of Q4.

Lipocine ( LPCN ) said it has confirmed with the US Food and Drug Administration its acceptance of a proposal for a 505[b][2] NDA filing, based on a single pivotal study comparing LPCN 1154 exposure with the approved IV infusion of brexanolone.

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