Lipocine Inc., a biopharmaceutical company leveraging its proprietary technology platform to develop innovative products with effective oral delivery, announced the completion of a scheduled independent Data Safety Monitoring Board review of its ongoing Phase 3 clinical trial evaluating LPCN 1154 (oral brexanolone) for the rapid relief treatment of PPD. This was the first of two DSMB reviews planned during the study and conducted after approximately one-third of planned 80 participants completed at least the day seven follow-up visit (n=30). The DSMB recommended that the trial continue as planned without modification.
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47 participants have completed dosing to date and there have been no treatment discontinuations or dose reductions required, and no reports of drug-related serious adverse events. No cases of excessive sedation or loss of consciousness have been reported to date in the development of LPCN 1154.
“We are encouraged by the safety profile observed in our clinical experience to date with our oral product candidate comprising GABAA positive allosteric modulating neuroactive steroid with low sedation,” said Mahesh Patel, CEO of Lipocine. “Target attributes of LPCN 1154, including superior tolerability, rapid relief, and a 48-hour treatment duration, could be a game changer in the treatment of PPD, a debilitating and life-threatening condition. We look forward to LPCN 1154 Phase 3 study results, expected in the second quarter of 2026.”
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About the Phase 3 Study
The pivotal, randomized, double-blind study is evaluating LPCN 1154 compared to placebo in women aged 15 years and older diagnosed with severe PPD. Following constructive feedback from the U.S. Food and Drug Administration (FDA), the trial is being conducted entirely in an outpatient setting and does not require medical monitoring by a healthcare provider. Nineteen clinical sites across the United States are participating. The readout from the second interim DSMB meeting and the safety update is targeted for early in the first quarter of 2026. Data from this Phase 3 trial are expected to support a 505(b)(2) NDA submission for LPCN 1154 in 2026.
About LPCN 1154
LPCN 1154 is an oral formulation of brexanolone in development targeted for administration resulting in rapid relief of PPD. While it is expected that LPCN 1154 could be the first line treatment choice for women with PPD, it may have characteristics that could be particularly appealing to patients with PPD, acutely elevated suicide risk, and in whom rapid improvement is a priority while presenting no significant risk of adverse reactions to breastfed infants from exposure to brexanolone.
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Source- PR Newswire
