Progress Report: Second Interim Safety Review of Phase 3 Trial of LPCN 1154 in Postpartum Depression

Lipocine today announced the completion of a scheduled independent Data Safety Monitoring Board (DSMB) review of its ongoing phase 3 clinical trial evaluating oral brexanolone (LPCN 1154) for the rapid relief treatment of postpartum depression (PPD). This was the second of 2 DSMB reviews planned during the study; the DSMB recommended that the trial continue as planned with no modifications.¹

The DSMB recommendation was based on assessment of available safety data collected from 82 randomized participants, of which 74 had completed dosing. There have been no treatment discontinuations or reports of drug-related serious adverse events. No cases of excessive sedation or loss of consciousness have been reported to date. The 1 reported case of a dose reduction was due to an adverse event.

LPCN 1154 is an oral formulation of brexanolone that is being developed to provide rapid relief of PPD in a convenient, at-home setting. It has potential to be the first line treatment choice for women with PPD while presenting no significant risk of adverse reactions from exposure to breastfed infants. It also has characteristics that could be particularly beneficial to patients with severe PPD, including those with elevated suicide risk, for whom rapid improvement is a priority.

The pivotal, randomized, double-blind study is evaluating LPCN 1154 compared with placebo in women aged 15 years and older diagnosed with severe PPD. Following constructive feedback from the US Food and Drug Administration, the trial is being conducted entirely in an outpatient setting and administration of LPCN 1154 does not require medical monitoring by a health care provider. Investigators anticipate that data from this phase 3 trial are expected to support a 505(b)(2) NDA submission for LPCN 1154 in 2026.²

The study is no longer screening new participants; however, Lipocine continues to enroll additional participants who have met the eligibility criteria and is on track to report topline safety and efficacy results early in the second quarter of 2026.

"The data generated to date reinforces our confidence in the safety profile of LPCN 1154," said Mahesh Patel, the CEO of Lipocine. "We believe LPCN 1154's target profile, including superior tolerability, rapid therapeutic benefit, and a short 48-hour treatment course, has the potential to establish a new and improved treatment paradigm for PPD. We look forward to sharing results from our phase 3 study in the second quarter of 2026."

References

1. Lipocine reports encouraging progress post second interim safety review in phase 3 trial of LPCN 1154 in postpartum depression (PPD). News release. January 12, 2026. Accessed January 12, 2026. https://www.prnewswire.com/news-releases/lipocine-reports-encouraging-progress-post-second-interim-safety-review-in-phase-3-trial-of-lpcn-1154-in-postpartum-depression-ppd-302657662.html

2. Lipocine highlights promising interim safety profile in phase 3 trial of LPCN 1154 in postpartum depression (PPD). News release. November 18, 2025. Accessed January 12, 2026. https://www.prnewswire.com/news-releases/lipocine-highlights-promising-interim-safety-profile-in-phase-3-trial-of-lpcn-1154-in-postpartum-depression-ppd-302617859.html