Lipocine Inc. (NASDAQ: LPCN) announced that its experimental drug LPCN 1154 failed to meet the primary endpoint in a Phase 3 trial for postpartum depression treatment.

The study of 90 patients showed LPCN 1154, an oral formulation of brexanolone, did not demonstrate a statistically significant reduction in HAM-D17 depression scores compared to placebo at the 60-hour mark, which was the trial's primary endpoint.

The drug showed a favorable safety profile with no treatment-related severe adverse events, cases of excessive sedation, or treatment-related discontinuations reported. No adverse event occurred in more than 5% of patients receiving LPCN 1154.

In a post hoc analysis of 54 participants with a history of psychiatric conditions, LPCN 1154 showed statistically significant reductions in depression scores compared to placebo. At 12 hours, the drug demonstrated a 7.2-point improvement over placebo, with effects sustained through day 30.

Based on this subset analysis, Lipocine has applied for breakthrough therapy and fast track designations from the FDA for LPCN 1154 in postpartum depression patients.

The company stated it plans to preserve capital and evaluate options including continued development, potential validation study protocols, strategic transactions, partnerships, and other opportunities while awaiting FDA feedback on the designations.

LPCN 1154 was developed as an oral treatment for postpartum depression, designed to provide rapid relief without requiring healthcare provider monitoring during administration.