The Food and Drug Administration (FDA) has approved Zulresso (brexanolone; Sage Therapeutics) injection for the treatment of postpartum depression in adult women, the first drug to be approved for this indication.

Zulresso, an analogue of the endogenous human hormone allopregnanolone, is intended for continuous intravenous (IV) infusion over 2.5 days following a titration schedule. It must be administered by a healthcare provider in a certified healthcare facility under close monitoring. Zulresso should not be given to patients with end stage renal disease (ESRD) due to potential accumulation of the solubilizing agent.

The primary outcome was the mean change from baseline in depressive symptoms as measured by the HAM-D total score at hour 60 (end of infusion). In both studies, treatment with Zulresso (titrated to target dose 90mcg/kg/hr) proved superior vs placebo in improvement of depressive symptoms at the end of the first infusion (LS mean change from baseline [Study 1]: -17.7 vs -14.0; [Study 2]: -14.6 vs -12.1) There was also improvement in depression at the end of the 30-day follow-up period.

Sleepiness, dry mouth, loss of consciousness, and flushing were the most common adverse reactions reported by study patients who received Zulressa. If the postpartum depression worsens or suicidal thoughts and behaviors arise, healthcare providers should consider an alternative therapy. It carries a Boxed Warning describing excessive sedation and sudden loss of consciousness.

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“Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient,” stated Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.

Zulresso will be available as a 100mg/20mL strength preservative-free solution in single-dose vials that requires dilution. The drug is pending controlled substance scheduling by the Drug Enforcement Agency (DEA).

For more information call (844) 472-4379 or visit SageRx.com.