Zuranolone was shown to be safe for use in a recent phase 3 clinical trial.
Now that it's been approved by the FDA, the agency will ensure the drug is held to its rigorous standards for safety and effectiveness.
Similar to Zulresso, an injectable medication that was granted FDA approval for postpartum depression in 2019, zuranolone provides rapid-acting antidepressant effects.
Deligiannidis explained the new oral version also supplies the brain with a neuroactive steroid similar to progesterone, which stimulates GABA receptors to modulate acute and chronic stress.
She described the FDA’s approval of Zulresso (brexanolone) as “a breakthrough for the field” but noted there have been barriers to receiving the medication for people with PPD.
Zuranolone is only intended for short-term use and has not been studied in pregnant people or those trying to conceive. Its safety has been studied for postpartum use only.