The Food and Drug Administration has approved zuranolone, the first-ever oral medication for postpartum depression.
One in seven mothers reports suffering from postpartum depression, a debilitating condition that occurs in the weeks and months after childbirth.
Katrina Furey, a Yale School of Medicine psychiatrist, says she suspects that figure is even higher due to unreported cases, which is why she applauds the FDA’s approval.
Zuranolone (brand name: Zurzuvae), is expected to be available in late fall. Price and insurance coverage details have not yet been announced. Sage Therapeutics in partnership with Biogen developed the drug.
“This is exciting because mental health issues are the most common complication of childbirth—beyond anything medical, including diabetes and hypertension,” Furey says. “Plus, the number one cause of maternal mortality is suicide, which is devastating. So, whatever we can do to get more treatments out there is important.”
Postpartum depression is the most common postpartum mental health condition; other types include postpartum anxiety, obsessive-compulsive disorder (OCD), and/or psychosis.
“Postpartum depression symptoms can be very similar to those associated with major depressive disorder, including low mood, tearfulness, poor sleep, as well as a lack of energy and concentration. It can include suicidal thoughts and an irritable mood,” she says.
Although symptoms can arise between two weeks and three months after giving birth, they typically occur within four weeks, she says. “But women can be diagnosed with the condition all the way up through one year postpartum.”
Treatment for postpartum depression is typically a combination of psychotherapy and medication, although patients with mild symptoms may respond to psychotherapy alone, Furey says.
“And while standard antidepressant medications can help with symptoms, they may take two to eight weeks to work. The advantages of zuranolone are that it takes about three days to work, and you only need to take it for two weeks.”
Prior to this pill, the only medication approved for postpartum depression was brexanolone, which was also developed by Sage Therapeutics and marketed as Zulresso. It requires a 60-hour intravenous infusion, which must be given in a hospital, and carries risks, including loss of consciousness.
Here, Furety talks about postpartum depression and zuranolone:
Postpartum depression vs. the ‘baby blues’
Postpartum depression is not to be confused with the “baby blues,” which almost all women experience after giving birth. During the third trimester, a woman’s levels of the hormones estrogen and progesterone are at their peak, and they plummet after delivery.
“When all your hormone levels drop in those first two weeks after delivery, you might feel like you’re losing your mind. But that’s normal, even if it doesn’t feel normal. It’s because the hormones dropped so quickly that your system needs to recalibrate,” Furey says.
With the baby blues, some women may feel intensely emotional or overwhelmed for a few days after giving birth; for others, it may last for two weeks. In most cases, though, the baby blues are an adjustment period due to the hormonal changes, and the feelings resolve without medical help.
But if sadness and irritability persist longer than two weeks, a woman should consider asking her medical provider if she should be screened for postpartum depression.
“If a woman is already connected to a therapist or psychiatrist, that’s a natural place to start. If not, her obstetrician, primary care provider, or baby’s pediatrician are good places,” Furey says.
In terms of what to look for, “PPD can be where you’re crying a lot more easily, you can be really irritable and snapping at people, and you take everything really critically,” she says. “You’re critical of yourself and thinking others are criticizing you.”
A diagnosis of postpartum depression requires that at least five depressive symptoms last for more than two weeks and are present almost every day. In addition to the symptoms Furey describes, these can include loss of interest or pleasure, insomnia or hypersomnia (excessive daytime sleepiness), agitation, feelings of worthlessness or guilt, loss of energy or fatigue, impaired concentration or indecisiveness, suicidal ideation, and changes in weight or appetite.
How does zuranolone work?
Zuranolone is a synthetic form of allopregnanolone, a naturally occurring neurosteroid that the body makes from the hormone progesterone. Allopregnanolone helps the GABA-A receptors, which regulate mood and behavior, work a little better.
“And that leads to calming, antidepressant properties,” Furey says. “When a woman has postpartum depression, she doesn’t have enough allopregnanolone and her GABA-A receptors aren’t firing right, which is what makes her irritable, anxious, and depressed, among other symptoms.”
Is zuranolone safe?
A Phase III clinical trial involving new mothers diagnosed with postpartum depression showed significant improvements In depressive symptoms in as little as three days. The women in the study took the pill once a day for 14 days and were followed for 45 days. (It is not yet known how long the effects of the medication will last beyond the 45-day trial period.)
The main side effects reported were sleepiness and dizziness. Women are advised to not drive for at least 12 hours after taking each dose of zuranolone. There was no evidence of withdrawal upon stopping the medication.
Can women breastfeed while taking zuranolone?
Because zuranolone passes into a woman’s breast milk and it’s not yet known if it can harm a baby, women in the study did not breastfeed while taking the medication.
“That, I think, is the biggest hiccup right now with this medication and something I’m sure will be studied further. A woman could pump and dump her milk for the duration of treatment. Or maybe she’s not nursing anyway. Or maybe if her symptoms are so severe, it makes sense to transition to formula so she can focus on her own mental health,” Furey says.
“But it’s unfortunate since nursing can be an important bonding experience that can help alleviate postpartum depression symptoms. However, for many women, nursing can also add stress.”
Could zuranolone work for other forms of depression?
Sage Therapeutics sought FDA approval to use zuranolone for major depressive disorder but failed to gain it because of mixed clinical trial results.
“The clinical trial results for zuranolone for postpartum depression showed a significant drop in the rating scale used to gauge depressive symptoms and saw improvement within three days of treatment, which is astounding,” Furey says.
“But when they looked at it for major depressive disorder, they didn’t see that. To me, that suggests that the biology of postpartum depression is completely different from major depression, even if the symptoms are similar.”
In the end, one pill is not a panacea for a major problem that affects many women, Furey says. “However, this is a big step in the right direction.”
For information about postpartum depression, call (800) 944-4773, text “Help” to (800) 944-4773 or visit Postpartum Support International.
Source: Yale University
