April 17, 2019 – Brexanolone
Anchor lead: One in five women may experience depression after giving birth, and a new drug may help, Elizabeth Tracey reports
Brexanolone, marketed as Zulresso, is a newly FDA approved drug for postpartum depression. Lauren Osborne, a postpartum depression expert at Johns Hopkins, describes how this drug is different.
Osborne: It’s operating by this completely novel mechanism for an antidepressant drug. It’s not related to the serotonin system, it’s related to this hormonal system, and it’s exciting to have a drug with a brand new mechanism be approved. The early studies with this drug showed that 70% of women went into remission. The later phase 3 trials not quite as different from placebo as the earlier ones. We don’t yet know a lot about the safety of breastfeeding, people have to stay inpatient for three days, it’s something like $34,000. The problem right now is going to be access. :31
Osborne says studies to more completely assess the impact of the drug on breastfeeding infants are underway, as is an effort to develop an oral formulation, which should reduce both cost and improve convenience. At Johns Hopkins, I’m Elizabeth Tracey.