Lipocine Inc. reported that the final patient in its Phase 3 study of LPCN 1154, an oral brexanolone for severe postpartum depression, completed the last scheduled visit on February 18, 2026. The randomized, double‑blind, placebo‑controlled trial enrolled 90 women across 19 U.S. sites and recorded a mean baseline Hamilton Depression Rating Scale score of 28.3. All nervous‑system adverse events were mild to moderate, and no drug discontinuations, excessive sedation, loss of consciousness, or serious drug‑related events were observed.
The milestone de‑risks the development program and positions Lipocine to file a 505(b)(2) New Drug Application later in 2026. With the withdrawal of the intravenous brexanolone (Zulresso) from the U.S. market in April 2025, the oral formulation offers a convenient at‑home alternative that could become a first‑line treatment for postpartum depression, a condition that affects millions of new mothers and for which rapid, safe therapies are scarce.
Lipocine’s cash and cash equivalents stood at approximately $19 million as of January 31, 2026. The company will need to raise additional capital to fund the NDA submission, potential regulatory review, and a commercial launch, but the current runway provides a buffer for the next 12–18 months of development and regulatory activities.
CEO Mahesh Patel said the high study‑drug compliance and favorable safety profile were attributable to the short, 48‑hour treatment duration and the regimen’s ease of use. He added that, if efficacy results are positive, the established safety profile could encourage prescribers to adopt LPCN 1154 as a patient‑centric option for women with postpartum depression.
Investors have expressed optimism about the company’s pipeline, citing the Phase 3 milestone and the potential market opportunity created by Zulresso’s exit. Analysts note that the safety data and the oral delivery platform strengthen Lipocine’s competitive positioning in the postpartum depression market.
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