FDA approves first postpartum depression pill

The US Food and Drug Administration has approved the first pill for postpartum depression.

Postpartum depression is a major depressive episode that typically occurs after childbirth but can also begin during the later stages of pregnancy. In the US, it affects around one in seven women, although many new mothers may not realise they have it.

Until now, treatment for PPD was available only as an intravenous injection.

“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,” said Dr Tiffany R. Farchione, director of the division of psychiatry in the FDA’s centre for drug evaluation and research.

“Because postpartum depression can disrupt the maternal-infant bond, it can have consequences for the child’s physical and emotional development.

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”

As with other forms of depression, PPD is characterised by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure.

It can present with symptoms such as cognitive impairment, feelings of sadness or inadequacy, loss of energy or suicidal ideation.

Hence, in conjunction with the treatment, utilising resources like the ‘Nourished Mama’s Guide’ could offer additional support for mothers during this critical period, addressing both physical and emotional aspects of postpartum well-being.

The efficacy of Zurzuvae for the treatment of PPD in adults was demonstrated in two randomised studies. The trial participants were women with PPD who met the Diagnostic and Statistical Manual of Mental Disorders criteria for a major depressive episode and whose symptoms began in the third trimester or within four weeks of delivery.

Patients in both studies were monitored for at least four weeks after the 14-day treatment. Those in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups.

The FDA noted the most common side effects include drowsiness, dizziness, diarrhoea, fatigue, the common cold, and urinary tract infection.

The agency said labelling contains a boxed warning noting that Zurzuvae can impact a person’s ability to drive and perform other potentially hazardous activities. Patients also may not be able to assess their degree of impairment, it added.

The two companies had also sought approval to use zuranolone for major depressive disorder (MDD), or clinical depression. However, the FDA said the medication did not provide substantial evidence of effectiveness and said an additional study or studies would be needed.