The Food and Drug Administration approved the first pill for postpartum depression last Friday — promising more accessible treatment for a potentially life-threatening condition affecting one in seven women in the US, most commonly within 6 weeks of childbirth.
Details: The drug, Zurzuvae (zuranolone), was administered as a 50 mg pill daily over two weeks and was compared to a placebo — studying its effects in reducing the symptoms of postpartum depression.
- The patients were monitored for at least four weeks after the two-week treatment ended — studying the change in depressive symptoms at day 15.
- The zuranolone group reported a significant improvement in depressive symptoms just 3 days into the treatment.
- On day 15, the zuranolone group showed a 29.4 percent greater improvement based on a rating scale compared to the placebo group.
- According to the study, improvements persisted for 45 days after the treatment ended. Similar results were observed in a study administering a lower dose of zuranolone.
Side effects: Zurzuvae comes with a black box warning noting that it can affect a person’s ability to drive and perform “other potentially hazardous activities.”
- The most commonly reported side effects include drowsiness, dizziness, diarrhea, fatigue, upper respiratory tract infection, and urinary tract infection.
- The study excluded patients who had the onset of their current depressive episode during pregnancy or at 4 weeks postpartum, who had treatment-resistant depression (TRD), or who were breastfeeding at screening.
Zuranolone is thought to work by acting as a positive allosteric modulator of GABA-A receptors — being a sister drug to brexanolone, an intravenous drug that was the first to be approved for treating postpartum depression.
- Studies have associated depression with reduced levels of GABA (gamma-aminobutyric acid), a neurotransmitter, in the brain and cerebrospinal fluid.
- Drugs like zuranolone increase the activity of GABA-A receptor protein — reducing stress and anxiety levels.
- In contrast to traditional SSRIs, zuranolone provides rapid and more sustained relief.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” said Tiffany R. Farchione, director of the Division of Psychiatry for FDA’s drug evaluation department.
Postpartum depression — also known as “baby blues” — refers to the feeling of sadness that sets in after the exhaustion of childbirth.
- Postpartum depression can affect both parents, although is more commonly reported in mothers. It is believed to occur due to an interplay of hormonal, physical, and psychological changes that are experienced throughout pregnancy. In some cases, genetic factors might also be involved.
- Symptoms of postpartum depression may set in even before childbirth, and women may experience complications like hypertension and gestational diabetes beforehand.
Commonly experienced symptoms of postpartum depression (according to Cleveland Clinic) include:
- feeling sad, worthless, hopeless, or guilty
- feeling on edge
- loss of interest, energy, and motivation
- feeling anxious around your baby
- problems sleeping or excessive sleep
- changes in appetite
- suicidal thoughts
- thoughts of hurting your baby
Sage Therapeutics and Biogen, who jointly developed the treatment, also applied for approval of zuranolone for treating major depressive disorder — but FDA rejected the application due to lack of enough evidence.