Lipocine and FDA agree on acceptance criteria for pivotal study of LPCN 1154

Lipocine completed a meeting with the FDA and guidance for the appropriate acceptance criteria for the upcoming LPCN 1154 pivotal study. PPD is a major depressive disorder with onset either during pregnancy or within four weeks of delivery. LPCN 1154 is targeted to be a differentiated oral option with rapid-onset, robust efficacy, and short treatment duration as a mono or add-on therapy for patients with unresolved depression symptoms. Lipocine completed a meeting with the FDA with agreement on: confirmation of Lipocine’s proposal for a 505(b)(2) NDA filing based on a single pivotal study comparing exposure of LPCN 1154 with the approved IV infusion of brexanolone, the use of exposure parameters and criteria to assess comparable exposure to IV infusion brexanolone, consistent with the goal to file a New Drug Application in 2024, the company anticipates beginning the pivotal study program in Q1’24 with LPCN 1154 “to be marketed” formulation. Top line results from the study are expected by Q2 ’24.