The FDA has approved the first drug ever specifically for postpartum depression, Zulresso (brexanolone).
Zulresso is given intravenously. Because of concerns such as sudden loss of consciousness and extreme sedation after administration, the approval of the drug was given with a Risk Evaluation and Mitigation Strategy (REMS). This means that Zulresso will only be available through certified healthcare facilities where a patient can be monitored during the infusion, which takes 60 hours (2.5 days).
Zulresso should be available to women by the end of June.
The most common side effects reported by patients on Zulresso in clinical trials were sleepiness, dry mouth, loss of consciousness and flushing. If a patient’s depression becomes worse or they experience suicidal thoughts and behaviors while on Zulresso, healthcare providers should consider discontinuing the drug.
Zulresso’s efficacy was demonstrated in two double-blind, placebo-controlled trials. In both studies, Zulresso was superior to placebo in terms of reducing depressive symptoms at the end of the infusion and 30 days later.
The drug was granted both Priority Review and Breakthrough Therapy designations by the FDA.
The former is for investigational drugs that may offer a significant improvement in the treatment of a condition; the latter is given to drugs that address an unmet medical need.