Brexanolone: panacea for postpartum depression? Reply to: ‘Intravenous brexanolone for postpartum depression: what it is,how well does it work,and will it be used?’

Dear Editor,

I read the informative research article ‘Intravenous brexanolone for postpartum depression: what it is, how well does it work, and will it be used?’ by Faden and Citrome, ¹ with great interest. In this article, they have extensively evaluated the recently US Food and Drug Administration (FDA)-approved drug for postpartum depression, brexanolone. While appreciating their efforts, we wish to highlight some important observations.

The cost of a single course of treatment with brexanolone is around $34,000 excluding hospitalization costs. ² Screening and treatment of postpartum depression and psychosis with conventional treatment costs $943 per woman. ³ Thus, treatment with brexanolone for Postpartum Depression (PPD) costs around 36 times more as compared with conventional treatment. The long-term efficacy data of brexanolone is lacking. The available data on the effects of brexanolone are only up to 30 days after the completion of infusion. If the dosing regimen of brexanolone has to be repeated, it will further escalate the cost of therapy and the calculated cost difference.

The long-term safety data of brexanolone are lacking. The available data on the effects of brexanolone are only up to 30 days after the completion of infusion. ⁴ Antidepressants are associated with the risk of suicidal thoughts and behaviours. Due to the limited data available, the risk of developing these adverse effects with brexanolone is still to be explored. Patients are kept under close monitoring for worsening of depression and suicidal thoughts. Change of therapeutic regime is recommended in case the patient has worsening of symptoms or experiences emergent suicidal thoughts and behaviours during treatment. ⁴ A diagnosis of worsening of depression and suicidal behaviour can be challenging in a patient on a continuous intravenous (IV) infusion and will require intensive monitoring of the patient throughout the course.

For a breastfeeding woman, prolonged, continuous IV infusion can be a huge barrier for the acceptability of treatment for obvious reasons. Furthermore, the cost of therapy should not only include the cost of drug but also hospitalization costs, as well as impact on the quality of life of the patient during the administration of drug.

Restricted availability, high cost, complex protocols with long infusion periods requiring continuous monitoring, risk of loss of consciousness, excessive sedation, hypoxia and worsening of depression and suicidal thoughts seem to be serious issues with brexanolone for its wide acceptability for treatment of postpartum depression.