First Postpartum Depression Pill Awaiting FDA Approval: What to Know

Female in bed with newborn
A first-of-its-kind, fast-acting oral tablet for short-term treatment of postpartum depression may be available soon with a prescription. Christelle Leuvennink/Getty Images
  • A first-ever pill for postpartum depression, zuranolone, could receive FDA approval on August 5.
  • The fast-acting oral tablet is safe and effective for short-term use.
  • Prioritizing maternal mental health could help reduce maternal mortality rates in the U.S.

Mental health is at the forefront of the maternal healthcare crisis in the United States, with suicide accounting for 20% of postpartum deaths in the first year following childbirth.

Postpartum depression (PPD) occurs in 1 in 7 pregnancies but it often goes undetected during routine screenings.

While most new birthing parents experience the “baby blues” for a few weeks after delivery due to a drop in the pregnancy hormone progesterone, PPD lingers for months or longer, hindering daily functioning and impacting quality of life.

Now, a new first-of-its-kind drug shows promise as a fast-acting treatment for people with severe postpartum depression.

A double-blind, placebo-controlled phase 3 clinical trial recently found that an oral pill, zuranolone, was highly effective in alleviating postpartum depression after 14 days of use. 

The study, recently published in the American Journal of Psychiatry, showed the drug improved depressive symptoms in just three days, and the improvement was sustained four weeks after discontinuing the drug at day 45.

Currently under priority review, the Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 5 for zuranolone, according to the drug’s manufacturers, Sage Therapeutics and Biogen. 

If approved, zuranolone could be lifesaving.

Lead study author Dr. Kristina M. Deligiannidis, director of Women’s Behavioral Health at Zucker Hillside Hospital, Northwell Health, and professor of psychiatry and obstetrics & gynecology at Hofstra University, told Healthline she’s been studying new treatments for postpartum depression for the past 15 years.

“Many health conditions that affect women are understudied, leaving women with fewer treatment choices,” she said. “[The] development of [an] oral option may increase treatment access.”

Is the new postpartum depression pill safe?

Zuranolone was shown to be safe for use in the recent phase 3 clinical trial.

If approved by the FDA, the agency will ensure the drug is held to its rigorous standards for safety and effectiveness.

Similar to Zulresso, an injectable medication that was granted FDA approval for postpartum depression in 2019, zuranolone provides rapid-acting antidepressant effects.

Deligiannidis explained the new oral version also supplies the brain with a neuroactive steroid similar to progesterone, which stimulates GABA receptors to modulate acute and chronic stress.

She described the FDA’s approval of Zulresso (brexanolone) as “a breakthrough for the field” but noted there have been barriers to receiving the medication for people with PPD.

Zuranolone is only intended for short-term use and has not been studied in pregnant people or those trying to conceive. Its safety has been studied for postpartum use only.

How long do you take zuranolone before you see results?

The clinical trial reported subjects with severe postpartum depression saw statistically significant improvements that continued at days 15, 28, and 45 when researchers assessed symptoms using the Hamilton Depression Rating Scale

All clinical trials conducted with zuranolone studied a 14-day treatment course, Deligiannidis said, noting the drug is intended for use as an acute treatment course for PPD, not long-term use.

When asked how zuranolone measures up to the other FDA-approved drug, the injectable Zurlresso, Deligiannidis said there are currently “no head-to-head clinical studies” with the two drugs, so their comparative effectiveness is unknown. 

“Both Zulresso and zuranolone are associated with a rapid reduction of PPD symptoms,” Deligiannidis said.

What are the side effects and benefits of zuranolone?

Mild to moderate side effects of taking zuranolone for 14 days were reported. These included:

  • drowsiness
  • dizziness
  • sedation

The clinical trial shows subjects did not lose consciousness, experience withdrawal symptoms, or experience increased suicidal ideation or behavior.

Like other forms of antidepressant medications, such as selective serotonin reuptake inhibitors (SSRIs), some amount of zuranolone may be found in breast milk.

“We reported at the International Association for Women’s Mental Health 2022 Regional Meeting that compared with the maternal dose, amounts of zuranolone in breast milk were low,” Deligiannidis said.

What’s the difference between postpartum depression and depression?

Perinatal mood and anxiety disorders (PMADs) is an umbrella term for mental health conditions that may arise during pregnancy or up to one year postpartum due to various factors that may be tied to ongoing psychological, biological, and even social shifts. These may include:

Deligiannidis explained there are shared biological mechanisms that may lead to the development of clinical depression in the general population and postpartum people. 

But she noted that women who develop peripartum depression — the period before, during, and immediately after childbirth — may experience “greater brain sensitivity to stress” as hormones fluctuate due to impaired neuroactive steroid functioning. 

“This was the rationale for the research into neuroactive steroid treatments for peripartum depression,” she said.

What are the signs of postpartum depression?

Postpartum depression is often conflated with the “baby blues,” a short-term period describing feelings of sadness or emptiness experienced by the birthing parent shortly after delivery. These symptoms usually resolve on their own in a couple of weeks and do not require treatment.

For a person with postpartum depression, however, it can be difficult to identify their need for intervention and treatment, according to Dr. Eynav Accortt, PhD, clinical psychologist and assistant professor in the department of obstetrics and gynecology at Cedars-Sinai in Los Angeles.

A main red flag, Accortt told Healthline, is when a person’s symptoms interfere with their ability to function.

“Mood swings, crying spells, exhaustion, and anxiety are common symptoms mothers experience the first few weeks after giving birth. But when those feelings linger longer than two weeks and begin interfering with daily tasks, it can be a sign of postpartum depression,” she said. “[The] ‘baby blues’ are transient.” 

Most postnatal well visits screen for signs of postpartum depression up to six weeks using the Edinburgh Postnatal Depression Scale (EPDS), which includes 10 questions to assess thoughts and mood.

Screening for postpartum depression should be routine and extend beyond six weeks, Accortt said, since diagnoses are often missed.

“Universal mental health screening, education and referral for perinatal depression is long overdue,” she stated.

“Not all programs are immediately effective, therefore hospitals must initiate quality improvement (QI) studies to assess the new programs to ensure effectiveness and identify barriers.”

Other ways to treat postpartum depression

Both the new postpartum depression pill zuranolone and its injectible counterpart Zulresso are short-term treatments for severe postpartum depression. Depending on a person’s symptoms and circumstances, these treatments may not always be the best interventions.

‘Baby blues’

For the ‘Baby blues’ period experienced by the majority of new parents and other mild to moderate symptoms of anxiety or stress as a person adjusts to parenthood, Accortt recommended self-care, social support, and therapy groups.

Moderate to severe postpartum depression

Individual talk therapies, such as cognitive behavioral therapy (CBT) or interpersonal psychotherapy can be very effective for individuals who are still functioning but finding it difficult to manage their moods, Accortt said. 

“Therapy is usually provided in individual sessions by a reproductive psychologist or perinatal healthcare certified therapist who can understand the unique challenges and pressures of the reproductive period,” Accortt noted. 

“Medication can also be helpful for some moderate cases.”

Resources for postpartum mood changes and disorders

Free resources for people experiencing postpartum depression and other related mood disorders include Postpartum Support International and the National Maternal Mental Health Hotline: 1-833-9-HELP4MOMS (available 24/7).

Severe postpartum depression

When symptoms of postpartum depression become more severe, medication may be the most helpful intervention. (In rare cases, a person may develop postpartum psychosis, which is a medical emergency and requires inpatient treatment.)

For severe PPD, antidepressant medications like the SSRI sertraline are considered safe during pregnancy and nursing. These may be prescribed by a healthcare professional, and are usually recommended for six to 12 months.

You can also ask your doctor about the injectable Zulresso medication, which shows benefits within 72 hours, or, pending FDA approval, ask them about zuranolone.

“The best outcome for severe depression or anxiety is the combination of medication and talk therapies,” Accortt said.

Why postpartum depression treatment matters

Poor maternal health outcomes disproportionately affect People of Color and individuals with low socioeconomic status. More than 20 states now ban abortion or restrict the procedure earlier in pregnancy than the standard set by Roe v. Wade, which can worsen mental health outcomes.

An accessible, affordable postpartum depression pill like zuranole is an important step forward in addressing our maternal healthcare crisis.

Doctors should also be aware of their patient’s mental health history, Accortt said, as a history of depression and anxiety are “critical risk factors” for postpartum depression. 

“Help actually begins with proper education, particularly for the women themselves as well as partners and family members,” Accortt said.

“Educating the hospital community and general population about PMADs [perinatal mood and anxiety disorders] is critical. Until there is an understanding about how common this is and that effective treatment is available, families will continue to fall through the cracks.

Takeaway

The FDA will vote to approve a new postpartum depression pill zuranolone on August 5, making it available for prescription use.

If approved, the fast-acting short-term drug could improve the quality of life for millions of people experiencing postpartum depression and related mood disorders. It could even save lives.

Experts say screening for postpartum depression should be routine and ongoing to avoid misdiagnoses and improve treatment interventions to help tackle the maternal healthcare crisis.

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