First drug approved for PPD use to remain under REMS program.
An estimated one in nine women experience symptoms of postpartum depression. Symptoms include feels of anxiousness, pessimism, guilt, and irritability; loss of energy, problems concentrating; and thoughts of suicide or suicidal attempts.
Zulresso (brexanolone, Sage Therapeutics), is the first and currently only drug to be approved specifically to treat postpartum depression in adult women.
Administered as a continuous IV infusion over 60 hours (2.5 days), Zulresso is under a restricted “Zulresso REMS Program” due to risks of sudden loss of consciousness. For the entirety of administration, patients will need to remain in a certified clinical setting where a health care provider can monitor for excessive sedation, oxygen levels in the blood, and potential loss of consciousness.
The most common side effects patients reported after being treated with Zulresso in clinical trials were sleepiness, dry mouth, loss of consciousness, and flushing.
Antidepressants may also increase the risk of suicidal thoughts or actions in patients 24 years and younger.