FDA Approves First Drug for Postpartum Depression
March 20, 2019
For the first time in history, the Food and Drug Administration (FDA) has approved a drug specifically for treating postpartum depression (PPD). The groundbreaking drug, brexanolone, will offer a new hope to women struggling with the common pregnancy complication.
Postpartum depression is a serious condition where a mother suffers from depression linked to childbirth. Women who endure PPD usually struggle with feeling overwhelmed, empty, uncontrollably sad and constantly irritated. They also have trouble focussing and may not feel a connection with their newborn. In some severe cases, moms may have thoughts of harming themselves or baby.
How it Works
Brexanolone, also referred to as Zulresso, is given via an IV over the course of a 60-hour infusion, according to the FDA news release. It will only be available through a restricted program called the Zulresso REMS Program, meaning it must be administered in a medical facility or a hospital. But the upside to the long infusion is that the drug is fast-acting. Women saw a noticeable improvement of their symptoms just 24 hours after receiving the drug, NBC reports.
Zulresso’s effectiveness was shown in two clinical studies with participants who received a 60-hour continuous IV infusion of Zulresso or placebo and were then followed for four weeks. One study included patients with severe PPD and the other included patients with moderate PPD. The primary focus in the study was the change from baseline in depressive symptoms as measured by a depression rating scale. In both placebo controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period.
The drug is not believed to have any long-term safety concerns, and the most common side effects during the trial were drowsiness and dizziness. Steve Kanes, chief medical officer of Sage Therapeutics, the company that developed brexanolone, says he expects the drug to be safe for all mothers, including breastfeeding mothers, but they are waiting for an FDA ruling on breastfeeding, according to NBC.
How much will it cost?
The one caveat to the monumental drug is its steep price tag. Sage says the drug is expected to cost between $20,000 to $35,000 for the infusion, not including the price of staying in the hospital for the treatment. Right now, it’s also unclear how much insurance would cover.
Nonetheless, the drug marks a major moment for new moms. Up until now, mothers experiencing PPD have been prescribed the same antidepressants used for treating depression in the general population. Not only can these take weeks to kick in, they don’t address the hormonal changes that women go through during and after pregnancy.
We’ve been failing moms for too long, but the new drug gives much-needed medical attention to PPD. Hopefully it will lead to even more advances and options to help mothers struggling to cope.