Fast-Acting and Effective Treatment for Postpartum Depression Gets Green Light From FDA, But Faces Considerable Challenges

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This week, the FDA approved brexanolone, a fast-acting, potentially game-changing treatment for postpartum depression that relieves even severe symptoms of the debilitating condition, which can seriously impair a mother’s ability to bond with and care for their newborn and may set the mother up for major depression down the road. This is the first ever drug tailored to women suffering from PPD and will be marketed under the name Zulresso.

PPD is currently treated through conventional antidepressants that may require weeks to take effect, if they’re effective at all. Brexanolone, on the other hand, is administered as a one-time IV infusion and is effective as soon as 48 hours after the initiation of the treatment. The drug is most effective for women who suffer from severe cases of PPD, but will also be significant for patients whose depression does not respond to conventional treatments. With brexanolone, relief from PPD’s symptoms — including depressed mood, anxiety, and thoughts of self-harm or harming the baby — lasts for at least one month after an infusion.

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The treatment needs to be administered in a healthcare facility via a 60-hour-long continuous IV infusion under constant medical supervision. If Medicaid and private insurers choose not to cover brexanolone, patients will need to be able to pay $34,000 for a single treatment. Needless to say, many publications have pointed out that despite the excitement surrounding the new treatment and its effectiveness, its cost and method of administration are going to be prohibitive for many of the patients who need it most, considering that about half of all births in the U.S. are covered by Medicaid. Others have also wondered whether there’s enough infrastructure in place for the treatment to even be accessible at all to the public.

Dr. Samantha Meltzer-Brody, one of the researchers involved in brexanolone’s clinical trials, acknowledged these concerns but felt that even just the high-profile news of its approval will help women get treated for postpartum depression. “[One] of the things that’s great about a drug specifically developed for postpartum depression, I think, is it’s increasing awareness,” she said in a conversation with PBS NewsHour. Meltzer-Brody reiterated how important it is for new mothers to be familiar with PPD so that they can alert their health care providers if they are experiencing any of its symptoms, rather than brushing it off as “just a phase” or a normal period of adjustment.

The $34,000 price tag of brexanolone is one aspect of the treatment that is continuing to fuel the conversation around PPD and to the broader issue of women’s access to postnatal care. NPR cited a report that found, perhaps unsurprisingly, that PPD is more prevalent among women with lower incomes and higher debt, as well as those who experience poor birth outcomes such as low birth rate and premature delivery; these conditions factor into why black and Latina women have higher rates of postpartum depression than whites. A separate report by the CDC found that Native American women and mothers under the age of twenty have the highest rates of all.

“Logistically it will be challenging,” Nancy Byatt told NPR; Byatt is a medical director who works in the field of postnatal mental health. “There will [have to] be centers that will be infusion centers for women with postpartum depression.” 

Meltzer-Brody had a different point of view, suggesting that the treatment could be given in any facility equipped to deliver babies. “I think the world is going to evolve to accommodate this,” she said.