What to Know About Zuranolone, the First Pill for Postpartum…

For the first time, a pill for postpartum depression, Zurzuvae (zuranolone), has been approved by the FDA.

Clinical trials have shown the fast-acting oral tablet to be safe and effective for short-term use.

Prioritizing maternal mental health could help reduce maternal mortality rates in the U.S.

A first-of-its-kind drug to treat postpartum depression was approved by the Food and Drug Administration (FDA) approved on August 4.

The oral pill, Zurzuvae (zuranolone), has shown promise in clinical trials as a fast-acting treatment for postpartum depression (PPD).

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

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

“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. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Dr. Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research 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.”

The new postpartum depression pill, developed by Sage Therapeutics in partnership with Biogen, will be marketed and sold as Zurzuvae. Sage-Biogen also attempted to expand the market for the drug as a treatment for major depressive disorder but was rejected by the FDA due to a lack of research on its effectiveness.

For now, the FDA’s approval of Zurzuvae for postpartum depression offers hope for the half-million birthing parents affected by the condition each year.

PPD diagnosis is often missed, zuranolone may improve treatment

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.

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

The Centers for Disease Control and Prevention (CDC) estimates postpartum depression occurs in 1 in 8 pregnancies. Despite its prevalence, postpartum depression often goes undetected during routine screenings.

The FDA’s approval of zuranolone draws awareness to a debilitating mental health condition, which could help reduce stigma, improve screening, encourage more people to seek treatment, and ultimately, save lives.

Dr. Kristina M. Deligiannidis, lead author of the clinical trials for zuranolone and director of Women’s Behavioral Health at Zucker Hillside Hospital, Northwell Health, and associate professor at the Feinstein Institutes for Medical Research in Manhasset, NY, 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 a recent phase 3 clinical trial.

Now that it’s been 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:

major depressive disorder (MDD)

generalized anxiety disorder (GAD)

obsessive-compulsive disorder (OCD)

post-traumatic stress disorder (PTSD)

panic disorder (PD)

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.”

Postpartum depression types and treatments

Both the new postpartum depression pill Zurzuvae and its injectable 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’

The ‘baby blues’ do not always lead to a postpartum depression diagnosis. Still, the feelings that may arise in the days and weeks following childbirth could sometimes seem overwhelming.

If you’re experiencing mild to moderate symptoms of anxiety or stress as you adjust to parenthood, Accortt recommends 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, a medical emergency requiring 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, the new FDA-approved pill, Zurzuvae.

“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 could 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 approved a new postpartum depression pill zuranolone on August 4, making it available for prescription use.

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.

Posted : 2024-05-28 14:46

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