FDA Approves First Drug for Postpartum Depression, Zulresso (brexanolone)

WEDNESDAY, March 20, 2019 -- Postpartum depression is a common and often devastating condition for new mothers, but the U.S. Food and Drug Administration on Tuesday approved the first drug to help combat it.

The drug, Zulresso (brexanolone), is delivered via intravenous infusion.

"Postpartum depression is a serious condition that, when severe, can be life-threatening," noted the FDA's Dr. Tiffany Farchione. "Women may experience thoughts about harming themselves or harming their child."

The condition "can also interfere with the maternal-infant bond," added Farchione, who is acting director of the Division of Psychiatry Products in the agency's Center for Drug Evaluation and Research.

The FDA decision "marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," she said in an agency statement.

Psychiatrist Dr. Martha Wald agreed that women battling postpartum depression have long needed new options.

"There is tremendous stigma around postpartum depression for women," said Wald, a psychiatrist and psychoanalyst at Duke University, in Winston-Salem, N.C. "Many women experience great shame and feel inadequate as mothers if they struggle with depression at a time that is supposed to be joyous."

"Because of this stigma, many women choose to not seek help and endure great suffering in silence," she said. "Postpartum depression affects 15 to 20 percent of the general population, and at least half of this group goes untreated. As more targeted treatments like this become available, more mothers are likely to seek and benefit from treatment."

Works in a new way

Dr. Kristina Deligiannidis was the lead investigator on the clinical trials that led to Zulresso's approval. She said the drug acts in a way that's different from other antidepressants.

Zulresso "acts on the main inhibitory neurotransmitter system in the brain, the GABA system," explained Deligiannidis, who helps direct women's behavioral health at Zucker Hillside Hospital, in Glen Oaks, N.Y.

The drug's active ingredient is synthetic allopregnanolone, a steroid that the body also makes naturally.

"Allopregnanolone is known to modulate the stress response system in humans, which has been shown to be abnormally functioning in women with postpartum depression," Deligiannidis explained.

And unlike typical antidepressants, which take four to six weeks to show an effect, Zulresso "works fast -- in 60 hours patients had reduced depression severity," she added.

According to the FDA, the results of two clinical trials led to Zulresso's approval -- one involved women with moderate postpartum depression, while the other involved women with a more severe form of the illness.

In both trials, women received intravenous infusions of either the drug or a placebo, and their depression symptoms were then tracked for a month.

In both cases, Zulresso outperformed the "dummy" placebo infusion.

Safety concerns

Deligiannidis said the drug was largely safe, with headache (about 16 percent of patients), dizziness (about 14 percent) and sleepiness (nearly 11 percent) being the most common side effects.

In rare cases, however, sedation was so profound that a loss of consciousness occurred, Deligiannidis said.

"In those patients that experienced loss of consciousness, this resolved within 15 minutes, and all excessive sedation events were completely resolved within 90 minutes," she said. "In three cases, the infusion was restarted and concluded without recurrence of events."

However, because of this rare side effect, the FDA has mandated that a boxed warning accompany the drug. Patients who take Zulresso will need to be counseled on the risks of treatment, and the 60-hour (2.5 days) infusion must be done at a health care facility where the patient can be monitored. Until any sedating effect wears off, people who take Zulresso should not drive or operate machinery, the agency said.

Dr. Jennifer Wu is an obstetrician/gynecologist at Lenox Hill Hospital, in New York City. She wasn't involved in the development of the drug, but called it a "welcome option" for women.

Still, the fact that it needs to be administered in a specialized facility, and not at home, is a drawback, she said.

"Due to possibly needing to separate the mother and child, this would likely not be a first-line drug for postpartum depression," Wu said.

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Posted: March 2019