First drug for postpartum depression approved by FDA

by | June 29, 2019 5:00 am

Last Updated: June 26, 2019 at 2:10 pm


For the first time in history, a drug specifically indicated for postpartum depression (PPD) was approved by the Federal Drug Administration.
Zulresso (brexanolone) by Sage Therapeutics is shown to relieve symptoms of postpartum depression within 48 hours. Compared to previously approved antidepressants taking multiple weeks to take effect, this fast-acting antidepressant is the first of its kind.
The drug is administered by a continuous intravenous (IV) infusion with a total infusion time of 60 hours. The efficacy of Zulresso has been validated by two clinical trials: one including patients with moderate postpartum depression and the other including patients with severe postpartum depression.
While this is a breakthrough approval, this medication does not come without risks. Patients receiving Zulresso will require extensive monitoring by their physician, many having experienced worrisome side effects including loss of consciousness and excessive sedation. While these side effects are undoubtably concerning, severe cases of PPD may put a patient at risk for harming themselves or their newborn, which may warrant use of this medication.
The approval of Zulresso is a noteworthy landmark in the treatment of depression, giving many medical professionals hope for continual advancement in the future.

(Trenton Bridge is a doctor of pharmacy candidate at the University of South Carolina.)

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