Lipocine has initiated subject dosing in its two-arm, blinded, randomised Phase III trial of LPCN 1154 (oral brexanolone) for postpartum depression (PPD).
This follows feedback from the Food and Drug Administration (FDA), which has allowed the study to be carried out in an outpatient setting, without the need for medical monitoring by a healthcare provider.
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Lipocine is expecting to use the data from this trial to support a new drug application (NDA) submission in mid-2026.
The trial will assess the efficacy of the therapy against a placebo in women aged 15 years and older with severe PPD.
The treatment includes a 48-hour dosing time, a protocol derived from Lipocine’s pharmacokinetic bio-bridge study with injectable brexanolone.
Several US clinical sites are participating in this study.
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By GlobalDataThe primary endpoint of the trial is the change from baseline in the Hamilton Depression Rating Scale (HAM-D).
The trial will also assess changes from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A) to evaluate anxiety symptoms, alongside key tolerability and safety measures.
The size of the trial is calculated based on the treatment effect noted with injectable brexanolone approved by the US regulator.
Lipocine CEO Mahesh Patel said: “Given the unmet need for rapid relief, this Phase III trial is an important step in our development programme to bring LPCN 1154 to women suffering from postpartum depression.
“By offering a novel bioidentical oral treatment with a 48-hour treatment duration and expected robust efficacy, LPCN 1154 is designed to be a differentiated, rapid relief product with the potential to be the standard of care.”
Brexanolone is a bioidentical neuroactive steroid, allopregnanolone, which acts as a positive allosteric modulator of the gamma-aminobutyric acid (GABA) receptor.
LPCN 1154 is expected to be particularly beneficial for those with PPD, especially those with an acutely elevated suicide risk and a need for rapid improvement. Exposure to brexanolone also presents no significant risk of adverse reactions to breastfed infants.
