The US Food and Drug Administration (FDA) has approved Sage Therapeutics’ Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression (PPD) in adults.
Until now, treatment for PPD was only available as an IV injection given by a health care provider in certain health care facilities.
“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. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany Farchione, Director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
The efficacy of Zurzuvae was demonstrated in two randomised, double-blind, placebo-controlled, multicentre studies. In Study 1, patients received 50mg of Zurzuvae or placebo once daily in the evening for 14 days. In Study 2, patients received another zuranolone product that was approximately equal to 40mg of Zurzuvae or placebo, also for 14 days.
Patients in both studies were monitored for at least four weeks after the 14-day treatment. 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.
Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups. The treatment effect was maintained at Day 42 – four weeks after the last dose of Zurzuvae.
The FDA granted the application Priority Review and Fast Track designation.
Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World