The Food and Drug Administration recently approved the first drug intended to treat postpartum depression in adult women.
The federal approval marks a pivotal step in the development of treatments meant specifically for maternal depression—a highly stigmatized and often debilitating condition. Psychiatrists at Duke are hopeful that the new drug—brexanolone—will bring attention to postpartum depression and the importance of mental health care delivery.
PPD affects as many as one in seven American women and can be life threatening for affected individuals.
“New mothers are supposed to rejoice in the wonders of their infants and ignore the discomforts of the emotional, physical and logistical demands placed on them,” wrote Marla Wald, assistant professor of psychiatry and behavioral sciences, in an email. “This stigma, and therefore embarrassment and reluctance to ask for help, contributes to a large percentage of women never seeking treatment.”
She explained that stigma surrounding mental health forces individuals to silently endure suffering. When it comes to PPD, the impact is even more staggering.
“It’s very difficult for many women to talk about this time in their lives as being as anything but ideal and wonderful,” said Christine Marx, professor of psychiatry and behavioral sciences. “There’s some internal conflict in terms of trying to voice some of these concerns.”
Because there have not been specific treatments targeting PPD until now, women and their families have felt little point in asking for help, Wald explained. The stigma around accessing treatment is further compounded by additional socioeconomic and racial factors.
"Stigma around mental health discourages people from seeking care at all," Wald said. "People are afraid to be identified as being thought of as 'weak' or 'not normal.' This is particularly true among young mothers."
What makes PPD unique among other mental health conditions is the crisis around the infant’s care that develops when the mother’s health is compromised. PPD interferes seriously with the maternal-infant bond, preventing affected mothers from bonding with their babies in the way that is crucial for healthy development.
“Women with severe PPD have impairment in being able to feed, change, hold and comfort their babies,” Wald said. “Now with the FDA approval of brexanolone, the landscape of treatment is changing and we now have a good, quick treatment option.”
Sold by Sage Therapeutics, Inc. under the brand name Zulresso, brexanolone relieves symptoms of depression for mothers and provides immediate relief. Standard antidepressants can take several weeks to work, or even worse, prove ineffective.
Brexanolone is the synthetic version of a naturally occurring steroid in the body, allopregnanolone. The IV infusion of brexanolone increases levels of this natural steroid before gradually lowering it.
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To minimize the risk of loss of consciousness that can accompany the drug as a side effect, brexanolone must be administered to patients via IV infusion over the span of 60 hours. Beyond the long time commitment required, administration of the drug also comes at the steep price of over $34,000, which doesn’t include the cost of inpatient care for the two-and-a-half day treatment.
“Trying to work on longer-acting formulations of this particular molecule would be a very fruitful undertaking,” Marx said. “We’re working in that particular area now—looking at longer-acting formulations of allopregnanolone.”
Wald explained that research is also ongoing to assess an oral, at-home administration of the medication, as well as to explore the utility of this medication for more moderate degrees of PPD, which are more frequently seen clinically.
Allopregnanolone has great therapeutic value not just for postpartum depression. It can help combat symptoms of post-traumatic stress disorder, traumatic brain injury, Alzheimer’s disease, schizophrenia and pain.
Marx's research at Duke and the Durham Veterans Affairs Health Care System is focused on developing longer-acting formulations of allopregnanolone to enhance adherence and access to these promising treatments.
Although there is still progress to be made to address the accessibility and cost of the drug, the FDA approval represents a promising step forward.
“While it takes 60 hours in a hospital setting to administer brexanolone at this point, the benefit to those mothers is clear,” Wald noted. “They are able to get back to their babies within a few days and function much better. This is in contrast to the weeks of oral antidepressant treatment needed to see similar benefit.”
The buzz generated around the approval of the medication has stirred conversation in a way that helps de-stigmatize maternal depression, Marx explained.
She elaborated that people discussing PPD more as "a neurobiological occurrence" clarifies that PPD is not viewed as "a sign of weakness."
"It's not something you did. It's not your fault," Marx said. "I think that will go a long way to trying to combat the disorder overall."