First Postpartum Depression Pill Awaiting FDA Approval

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 pregnanciesTrusted Source 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. “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 ZulressoTrusted Source, 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. 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 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. 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.