The first drug specifically for postpartum depression could be approved next month

Families with children in WakeMed’s neonatal intensive care unit have many costs – parking, food and hotel rooms – in addition to their medical bills. The Me Fine Foundation is expanding into WakeMed to help those families.
Families with children in WakeMed’s neonatal intensive care unit have many costs – parking, food and hotel rooms – in addition to their medical bills. The Me Fine Foundation is expanding into WakeMed to help those families. N&O file photo

Women who struggle with debilitating depression after childbirth could get relief soon from a new medication — the first drug created specifically for postpartum depression.

The medication, developed through research conducted at UNC Chapel Hill, could be approved for patients before Christmas.

Postpartum depression afflicts an estimated 1 out of 8 women after giving birth and can lead to suicide and harm to the baby.

The treatment is more complicated than taking a conventional anti-depressant pill. Because the new drug is dripped into the vein for a period of 60 hours, it requires medical supervision to make sure the patient doesn’t pass out. And it remains unclear if women will be able to breast-feed while they’re taking the medication.

Advocates for women who experience the condition, also called perinatal mood disorder, say that the benefits of the new medication will far outweigh any inconveniences.

“There’s tremendous excitement about it,” said Anne Wimer, a Cary resident who co-founded the Moms Supporting Moms weekly peer support group for women and is a North Carolina coordinator for Postpartum Support International. “If it’s approved it will be a huge breakthrough.”

Postpartum depression symptoms

When postpartum depression strikes, women report symptoms spanning anxiety, anger, despair, feelings of worthlessness, thoughts of harming the infant, and suicidal thoughts. Research indicates that these women can become so impaired that their children suffer developmental consequences for years to come.

“Indeed, the most common cause of maternal death after childbirth in the developed world is suicide,” the FDA said in public document about the disorder. “A depressive episode at this time in a woman’s life can not only deprive her of the enjoyment of a new infant, but can have serious effects on the maternal-infant bond and later infant development.”

The drug functions as a hormone that counteracts the hormonal fluctuations women with postpartum depression experience in the weeks and months after giving birth. Currently these women are treated with anti-depressants. What makes the new medication different is that it clears up maternal depression within days, rather than taking a month or longer to see if it works.

“It would be the first drug ever for postpartum depression,” said lead researcher Samantha Meltzer-Brody, director of Perinatal Psychiatry Program at the UNC School of Medicine. “It is a totally new mechanism of action. It is not a new version of Prozac.”

FDA concerns

The U.S. Food and Drug Administration will hold a public hearing on the drug, brexanolone, on Friday, to hear from patient advocacy groups and other interested parties, and to discuss the data from a 2-year clinical trial and results published in August in The Lancet, an international medical journal.

The FDA has indicated it expects to issue a decision on brexanolone by Dec. 19, and Sage Therapeutics, the Massachusetts pharmaceutical company seeking FDA approval, expects to start making it available to patients by mid-2019.

One of the unknowns about the drug is whether women can breast-feed during their infusion period. During the clinical trials, women had to “pump and dump” their breast milk, Meltzer-Brody said, but this restriction could be lifted when the drug is approved. Sage Therapeutics said the FDA could impose restrictions and warnings for the drug as a condition of approval.

Sage Therapeutics, a 500-employee company based in Cambridge, employs 30 people at its national patient support center in Raleigh. The company, which doesn’t have any medicines on the market, had previously developed brexanolone, then called Sage-547, for advanced epilepsy, but unsuccessful clinical trial results last year shifted the focus of the drug to postpartum depression.

Study results

Sage Therapeutics, which plans to market the drug under the name Zulresso, has not disclosed how much the drug would cost. The company said in an emailed statement: “Our pricing strategy will focus on the clinical value of Zulresso and the high unmet need.”

In The Lancet study, 209 women at 30 sites around the country participated in the clinical trial between 2016 and 2017, some taking a placebo, and some taking the medication. The study showed that about three-fourths of the women reported significant improvement and 94 percent of them kept depression at bay a month after they took the medication, Meltzer-Brody said.

“The overwhelming majority of people had a robust response,” she said. “A significant amount actually went into remission, which means the depression is completely resolved.”

Nearly a third of the women in the clinical trials experienced side effects such as headaches, sleepiness and dizziness, she said. The FDA’s biggest safety concern is fainting, which affected six of the 140 women who took the drug, according to the FDA briefing document for Friday’s hearing.

“An abrupt loss of consciousness can be dangerous to the patient (e.g., falls, drowning) and to the infant (e.g., drops, smothering),” the briefing document says. “Therefore, the Agency believes the patient must be continuously monitored and cannot function as her child(ren)’s primary care giver during the infusion.”

That means that women will likely have to spend at least two days and nights outside the home, either at a hospital or at a special clinic, if the FDA adopts the concerns of its medical experts. That would entail additional costs charged by the facilities and medical staff.

“We do not feel infusions must be done in an inpatient hospital setting,” the FDA briefing document said. “However, we do not feel it would be safe to allow home infusions at this time. Home infusions would require a healthcare professional on-site at all times.”

Resources for mothers

SAFEchild’s Moms Supporting Moms: 919-454-6946

Postpartum Support International: 800-944-4773

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