Postpartum depression, which affects as many as one in nine new mothers, can be life-threatening — and yet, the main treatments for this illness can take weeks to start working. But a new drug just approved by the U.S. Food and Drug Administration (FDA) can take effect in as little as two days.
The new drug, brexanolone injection for intravenous (IV), or Zulresso, is the first medication approved specifically to treat postpartum depression in adult women. And unlike antidepressants that can take weeks to work, this new drug can start working almost right away.
Postpartum depression (PPD) is a serious mood disorder that develops after childbirth. It’s characterized by sadness and/or a loss of interest in activities previously enjoyed, a decreased ability to feel pleasure, and symptoms like cognitive impairment, feelings of guilt or worthlessness, or suicidal ideation.
"Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond,” Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release.
This new medication provides an important treatment option. Currently, however, it’s only available to patients through certain health care facilities where the provider can monitor the patient.
The drug is given as a continuous IV infusion over two and a half days (60 hours). Risks include sedation and the sudden loss of consciousness—hence the need for careful monitoring during treatment. The most common side effects are sleepiness, dry mouth, loss of consciousness, and flushing.
In clinical trials involving women with moderate or severe PPD, Zulresso was significantly more effective than placebo at reducing depression symptoms at the end of treatment and 30 days later.
How does it work so fast?
The current mainstays for PPD treatment are similar to those for depression that occurs outside of the postpartum period: talk therapy and antidepressants, including SSRIs. But Zulresso works differently.
“[SSRIs] mostly affect the neurotransmitter serotonin, and take two to six weeks to begin working,” says perinatal psychiatrist Pooja Lakshmin, M.D., an assistant professor of psychiatry at the George Washington University School of Medicine. “Brexanolone [Zulresso] appears to have a novel mechanism of action — it is a [synthetic form of a hormone produced by] the human hormone progesterone, acts on the GABA neurotransmitter system [a part of the brain thought to control anxiety], and works much more quickly — within a few days.”
But despite the quick-acting nature of Zulresso, it may not be the right choice for every woman following childbirth, Dr. Lakshmin tells HealthCentral.
“Brexalonone [Zulresso] is for women with severe postpartum depression, whose illness is debilitating enough that they require hospitalization,” she says. “Women with mild to moderate postpartum depression are not going to be ideal candidates for this new treatment.”
There are two reasons for this, Dr. Lakshmin says:
- Patients with moderate PPD showed a “less dramatic therapeutic response” to the drug than those with severe postpartum depression.
- “The drug currently comes in only an IV form, and must be administered over 60 hours, in an inpatient setting, thus, limiting its use.”
And there’s another unfortunate catch, Dr. Lakshmin says: Zulresso is really, really expensive. Sage Therapeutics, the company that developed the drug, charges $34,000 for one course of the infusion. And that doesn’t include the cost of the hospital stay. (It’s not yet clear how or whether insurance companies and hospitals will cover the drug costs.)
While these factors mean that the majority of patients with PPD may continue to rely on antidepressants and talk therapy for treatment, Dr. Lakshmin says, the new drug’s approval is an important step forward. “[The approval] indicates that maternal mental health conditions are being taken seriously,” she says. “For those patients with severe illness, this new drug carries hope.”