In this Evidence Insight, Lumere’s research team reviews and analyzes the clinical evidence and clinical trial data related to Brexanolone.
Brexanolone: A Snippet
“Approved in March 2019, brexanolone is the first agent indicated for the treatment of postpartum depression.
However, brexanolone’s high acquisition cost and prolonged infusion time has led to questions about its role in therapy.
While psychotherapy is an effective guideline-recommended, first-line treatment for patients with postpartum depression, there is no consensus on appropriate second- or third-line treatments for more severe postpartum depression, and off-label use of multiple treatments and therapies are recommended for these patients.
The most common non-serious adverse events associated with brexanolone are sedation/somnolence, flushing, dry mouth, and dizziness. Rare serious adverse events include hypoxia, altered state of consciousness, syncope, and suicidal thoughts and behaviors.
Brexanolone also contains a boxed warning for excessive sedation and sudden loss of consciousness. Brexanolone was approved based on results from a series of phase 2 and 3 randomized controlled trials in which it demonstrated superiority over placebo at the end of infusion and through a 30-day follow-up period in patients with moderate to severe postpartum depression. Brexanolone is administered over a 60-hour infusion period in a healthcare setting at an acquisition cost of approximately $30,000.
It is only available through a Risk Evaluation and Mitigation Strategy program and is further associated with costs for prolonged administration, monitoring, and severe adverse event management.”