FDA approves first drug specifically for postpartum depression

Zulresso (brexanolone), developed by the biopharmaceutical company Sage Therapeutics, has been approved by the US Food and Drug Administration (FDA) pending the Drug Enforcement Agency (DEA) schedule.

Sage Therapeutics is the only medication specifically indicated for the treatment of postpartum depression (PPD), a life-threatening major depressive episode that occurs after delivery and characterized by decreased ability to feel pleasure. , cognitive impairment, feelings of worthlessness or guilt, and / or suicidal ideation.

Administered by continuous intravenous infusion for 60 hours, Zulresso is only available through a restricted program. The Zulresso Risk Assessment and Mitigation Strategy (REMS) Program requires that the drug be administered by a health care provider in a health facility and that patients be enrolled in the program prior to the administration of the drug .

The treatment consists of an allosteric modulator of synaptic and extrasynaptic GABAA receptors. The allosteric modulation of neurotransmitter receptor activity results in a variety of activity instead of activation or complete inhibition of the receptor.

Zulresso's approval comes after the efficacy of treatment has been demonstrated in two clinical students in which participants received a continuous 60-hour intravenous infusion of the drug or placebo. One study included patients with severe PPD and the other with moderate PPD patients.

The efficacy was based on the mean change in depressive symptoms by means of a depression badessment scale, Zulresso demonstrating its superiority over placebo in both studies at the end of the first infusion . An improvement in depression was observed at the end of a 30-day follow-up period.