US FDA greenlights first pill for postpartum depression

Elvira Manzano
31 Aug 2023
US FDA greenlights first pill for postpartum depression

The US Food and Drug Administration (FDA) has approved the first oral medication for postpartum depression in adults, giving clinicians a new therapeutic option for this debilitating condition.

In one study, more than twice as many women achieved remission after 2 weeks of treatment with zuranolone. The pill started to ease depression in as little as 3 days, faster than any antidepressant.

Prior to zuranolone approval, brexanolone is the only drug indicated for postpartum depression. However, it requires a 60-hour intravenous infusion in a hospital.

Finally, an oral option

“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness, and in severe cases, thoughts of harming themselves or their child,” said Dr Tiffany Farchione, director, Division of Psychiatry, US FDA Center for Drug Evaluation and Research. Symptoms of depression after childbirth vary and can range from mild to severe.

“As postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development. Having access to an oral medication will be a good option for many women coping with extreme, and sometimes life-threatening feelings,” she added.

Zuranolone supported by robust data

Two phase III trials involving 350 women support the approval of zuranolone for postpartum depression. The women met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode, with symptom-onset in the third trimester or within 4 weeks of delivery.

The primary endpoint of both studies was the change in depressive symptoms using the total score from the 17-item Hamilton depression rating scale (HAMD-17), measured at day 15.

Both studies met the primary endpoint. Those on zuranolone had a greater reduction on the HAMD-17 total score from 4.0 to 4.2 points at day 15 compared with placebo.

In one of the two studies, reductions in depressive symptoms were observed by day 3 and maintained at all time points through day 45. Additionally, there were improvements in anxiety symptoms. [JAMA Psychiatry 2021;78:951-959]

The most common side effects reported with the drug were drowsiness, dizziness, diarrhoea, fatigue, nasopharyngitis, and urinary tract infection.

A neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator, zuranolone 50 mg should be taken in the evening with a fatty meal over a 14-day course, either alone or as an adjunct to an oral antidepressant. The 30-mg dose is recommended for patients with severe hepatic impairment or moderate-to-severe renal impairment.

Zuranolone label will include warnings about possible suicidal thoughts and behaviour, sleepiness, and confusion. Women are also advised not to drive or operate heavy machinery for at least 12 hours after taking the pill. The label will also advise against using contraception while taking the pill and for a week after.

Depression after birth

“This is a patient population that just so often falls through the cracks,” commented Dr Ruta Nonacs from the Center for Women’s Mental Health at Massachusetts General Hospital in Massachusetts, US. “Women diagnosed with the condition often felt embarrassed. There is also a lot of stigma about taking antidepressants. What makes zuranolone more appealing is that it is targeted to postpartum depression.”

However, experts said longer-term data are needed to determine if patients relapse.

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