The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Zulresso (brexanolone) to include patients 15 years of age and older with postpartum depression. Previously, the treatment was approved only for adults 18 years of age and older.
The expanded approval was based on safety data from an open-label study in 20 patients aged 15 to 17 years with postpartum depression. Patients were titrated to a target dosage of 90mcg/kg/hour and were then followed for 4 weeks. Results showed that the adverse reactions reported in this patient population were generally similar to those observed in clinical studies of Zulresso in adults with postpartum depression. Additionally, brexanolone pharmacokinetics in patients 15 to 17 years old were found to be comparable to those in adults.
Zulresso, a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator, is intended for continuous intravenous infusion over a total of 60 hours following a titration schedule. It must be administered by a health care provider in a certified health care facility under close monitoring. Zulresso should not be given to patients with end stage renal disease due to the potential accumulation of the solubilizing agent, betadex sulfobutyl ether sodium.
Zulresso carries a Boxed Warning associated with the risk of excessive sedation or sudden loss of consciousness during administration. Due to these risks, the product is only available through a restricted program called the Zulresso REMS Program. The most common adverse reactions associated with treatment include sedation/somnolence, dry mouth, loss of consciousness, and flushing/hot flush.
Zulresso is a Schedule IV controlled substance. The 100mg/20mL strength preservative-free solution is supplied in single-dose vials that require dilution.
- US Food and Drug Administration: NDA 211371/S-007. Supplement approval/ Fulfillment of postmarketing requirement. Accessed June 21, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211371Orig1s007ltr.pdf
- Zulresso. Package insert. Sage Therapeutics, Inc.; 2022. Accessed June 21, 2022. https://assets.sagerx.com/zulresso/prescribing-information.pdf