ArticleClinical pharmacokinetics2022
Allopregnanolone Concentrations in Breast Milk and Plasma from Healthy Volunteers Receiving Brexanolone Injection, With Population Pharmacokinetic Modeling of Potential Relative Infant Dose.
Article in Clinical pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 24 citations in OpenAlex.
- An open-label, proof-of-mechanism trial evaluating a neuroactive steroid GABA modulator in tinnitus.Frontiers in neurology · 2025Trial
- Brexanolone, a First-In-Class Neurosteroid Medication: Mechanism of Action, Clinical, and Translational Science.Clinical and translational science · 2026Review
- First Reported Case of Dissociative Symptoms Associated With Zuranolone Use in Peripartum Depression.Cureus · 2026Article
- Maternal Milk Allopregnanolone May Buffer Negative Associations Between Maternal Postpartum Psychological Distress and Infant Regulatory Capacity.Developmental psychobiology · 2026Article
- Clinical study design and modeling approaches to study secretion of drugs in human milk.Frontiers in pediatrics · 2026Review
- New Agents in the Treatment of Psychiatric Disorders: What Innovations and in What Areas of Psychopathology?Pharmaceuticals (Basel, Switzerland) · 2025Review
- Clinical Utility of Zuranolone for Postpartum Depression: A Narrative Review.Neuropsychiatric disease and treatment · 2025Review
- Review
- Review
- Simultaneous Determination of Selected Steroids with Neuroactive Effects in Human Serum by Ultrahigh-Performance Liquid Chromatography-Tandem Mass Spectrometry.ACS chemical neuroscience · 2024Article
- Current pharmacotherapy approaches and novel GABAergic antidepressant development in postpartum depression.Dialogues in clinical neuroscience · 2023Review
- Preclinical and clinical pharmacology of brexanolone (allopregnanolone) for postpartum depression: a landmark journey from concept to clinic in neurosteroid replacement therapy.Psychopharmacology · 2023Review
- Zuranolone - synthetic neurosteroid in treatment of mental disorders: narrative review.Frontiers in psychiatry · 2023Review
- The value of midwifery counseling during lactation as a key factor of pharmacovigilance.European journal of midwifery · 2022Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveWomen with postpartum depression (PPD) may expose their infants to antidepressants via breast milk. Brexanolone is the only FDA-approved antidepressant specifically indicated for the treatment of PPD. This open-label, phase Ib study of healthy lactating volunteers assessed pharmacokinetic (PK) properties of brexanolone and a population PK (PopPK) model determined the relative infant dose (RID) in breastfeeding mothers.
methodsTwelve participants received a 60-h infusion of brexanolone (titration up to 90 µg/kg/h). Allopregnanolone concentration was measured in breast milk and plasma. The RID was computed using a nonlinear mixed-effects PopPK model of patients with PPD and healthy women (N = 156). Model results were extended across an integrated dataset of participants through day 7.
resultsAllopregnanolone concentration-time profiles were similar between breast milk and plasma (partition coefficient for concentration gradient [milk : plasma] 1.36). Mean (95% CI) C
conclusionThe PopPK model successfully described the variability and concentration-time profiles of allopregnanolone in breast milk and plasma in healthy participants and in the plasma of brexanolone-treated patients with PPD. The rapid elimination of allopregnanolone from plasma and breast milk, and low RID, suggests the appropriateness of brexanolone weight-based dosing and supports other PK-related labeling recommendations.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.