Lipocine Inc. announced the completion of 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, with symptoms persisting up to 12 months after childbirth. 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 resolved depression symptoms. Following positive results from the pilot PK bridge study, Lipocine completed a successful meeting with the U.S. Food and Drug Administration (FDA) on October 18th with agreement on the following: 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 (NDA) in 2024, the company anticipates beginning the pivotal study program in first quarter with LPCN 1154 "to be marketed" formulation. Top line results from the study are expected by second quarter '24.

The current approved standard of care is a continuous infusion of intravenous brexanolone which requires inpatient administration and has significant limitations.