Lipocine (NASDAQ:LPCN) experimental oral treatment for postpartum depression passed its final independent safety review, clearing the path for a critical data readout later this spring.
The company’s stock remained in focus Monday as the Data Safety Monitoring Board recommended the Phase 3 trial of LPCN 1154 continue without modification.
The positive safety assessment, the second of two planned reviews, was based on a pool of 82 randomized participants.
Crucially, the Salt Lake City-based drugmaker reported no serious drug-related adverse events, excessive sedation, or loss of consciousness—side effects that have historically complicated the administration of similar neurosteroid-based therapies.
Only one patient required a dose reduction due to an adverse event, and no participants have discontinued the treatment to date.
Lipocine is betting that an oral, at-home version of brexanolone will disrupt a market currently dominated by more cumbersome administration methods.
While existing treatments often require intensive medical monitoring or intravenous infusion, Lipocine’s candidate is being tested entirely in an outpatient setting without the need for healthcare provider supervision.
The treatment is designed as a short 48-hour course, targeting rapid relief for women with severe PPD.
Chief Executive Officer Mahesh Patel said the data generated so far reinforces the company's confidence in the drug’s tolerability and rapid therapeutic profile.
The company has stopped screening new participants and is finalizing enrollment for those already eligible.
Topline safety and efficacy results are slated for early in the second quarter of 2026.
If the study is successful, Lipocine expects to use the data to support a New Drug Application submission later in 2026.
The 505(b)(2) regulatory pathway targeted by the company could accelerate the timeline to market, potentially positioning LPCN 1154 as a first-line treatment for a condition that affects roughly one in seven new mothers.