Approval recommendation: New active ingredient for postpartum depression in sight

10 to 15 percent of Women suffer from depressive symptoms after giving birth, a postpartum depression . This can last for a longer period and, in addition to the mother's suffering, also negatively impacts the mother-child bond. To date, there are no treatments for this specific form of There is no explicitly approved treatment for depression ; depending on the severity of the symptoms, treatment is currently with antidepressants such as citalopram, which only pass into breast milk to a small extent.

Zuranolone (Zurzuvae® from Biogen and Sage Therapeutics) is a neuroactive steroid and acts as a positive allosteric modulator at the GABA _A receptor. In the pivotal Phase III SKYLARK study, 196 participants received 50 mg of zuranolone once daily or placebo for 14 days. 170 completed the study. The primary endpoint was an improvement in depressive symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D) on day 15. Symptoms improved by 15.6 points with zuranolone and by 11.6 points with placebo. The difference was statistically significant. In contrast to conventional antidepressants, initial improvements were seen after just three days and lasted until day 45 despite only 14 days of administration. The most common side effects were drowsiness, dizziness, and sedation. No suicidal thoughts or suicidal behavior occurred.

The approval recommendation refers to the treatment of postpartum depression and a 14-day treatment duration. Subject to the green light from the EU Commission, Zurzuvae will be marketed as a hard capsule in dosages of 20, 25, and 30 mg. The drug has been approved in the US since August 2023. The recommended dosage is 50 mg daily. The capsules should be taken in the evening with a high-fat meal. Zuranolone is excreted in breast milk; no effects on the infant are currently known.