FDA approves oral medication treating postpartum depression

A new drug treating postpartum depression was approved earlier this month by the Food and Drug Administration – possibly filling a gap in care, depending on the drug’s accessibility to the general public.

The Zurzuvae oral pill is administered once daily over a two-week period and can provide fast-acting relief for someone experiencing postpartum depression in the days and weeks after birth, according to studies observing women up to 45 days after birth.

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness – even, in severe cases, thoughts of harming themselves or their child,” Tiffany R. Farchione of the FDA’s Center for Drug Evaluation and Research said in a statement. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

According to the FDA, the studies conducted on the drug showed “significantly more improvement” in symptoms compared to placebo groups.

Dr. Robin Messinger, a Providence Sacred Heart obstetrician, called the drug “pretty impressive” in how quickly it becomes effective, compared to serotonin inhibitors, or SSRIs, that are used to treat depression now.

“This medication is very fast-acting compared to SSRIs, which may take weeks or even months to kick in. These appear to kick in within days,” Messinger said.

Messinger stressed that pharmaceuticals are only one part of a “multifocal” treatment plan for those with postpartum depression that also includes “social support, rest and therapy.”

Currently, SSRIs are the mainstay of a drug that is used to treat PPD, but it is not targeted to treat the causes of depression after birth. SSRIs work by increasing serotonin in the body, a lack of which is believed to be the main culprit behind generalized depression.

Postpartum depression is caused not by a deficiency of serotonin but by the sudden and precipitous drop in hormones immediately following birth. SSRIs can help treat PPD but will not impact the root of the issue, according to Messinger. Zurzuvae is “targeted specifically” to the issues seen in the postpartum period, she said.

Asked if she will consider prescribing the medication to her patients, Messinger said she would only consider it in instances of “severe postpartum depression” and would look to transition her patient back to SSRI after 45 days. Messinger is concerned about the possible price of the medication creating a “barrier” for many patients.

Multicare Rockwood clinic obstetrician Lacey Marks declined to comment on Zurzuvae specifically but said a drug specifically treating PPD is sorely needed.

“Having a new medication specifically designed for this disorder, I can only imagine is going to be helpful not only for the treatment of these women, but for the recognition amongst the community and in society that this condition exists,” Marks said.

Questions still remain about the drug’s affordability once it reaches market by the end of the year. In a video announcement, Chris Benecchi, Sage Biotech chief business officer, said it was “too early to talk about price” but that the company’s “goal” is for the drug to be accessed “regardless of financial circumstance.”

Sage also owns the other postpartum drug on the market called Zulestro, which launched in 2019 with a price tag in the tens of thousands of dollars. The drug also was not an oral pill, but administered as a one-time infusion over 60 hours.

Messinger said this treatment has been “very expensive” and “very difficult from an access standpoint.”

Sage and Biogen, which jointly developed Zurzuvae, also asked regulators to approve the drug for treatment of both postpartum depression and major depressive disorder, the form of depression diagnosed outside of the postpartum period. The FDA approved it for the former but not the latter.

The companies stated in a news release they are reviewing FDA feedback and evaluating their next steps for getting it approved for conditions beyond postpartum depression.

Side effects of Zurzuvae include drowsiness, dizziness, diarrhea, fatigue, the common cold and urinary tract infections. Those taking the drug should not drive for at least 12 hours.