Sage Therapeutics' Zulresso (brexanolone) has become first treatment to be approved for post-partum depression in the US.
PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy, thought to affect around one in nine women who have given birth in the US.
The condition is characterised by sadness and/or loss of interest in activities and a decreased ability to feel pleasure (anhedonia), and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.
The drug’s approval “represents a game-changing approach to treating PPD,” said Samantha Meltzer Brody, Ray M Hayworth Distinguished Professorship of Mood and Anxiety Disorders and director of the Perinatal Psychiatry Program, UNC Center for Women’s Mood Disorders and primary investigator of the Zulresso clinical trials. “The potential to rapidly reduce symptoms in this critical disorder is an exciting milestone in women’s mental health.”
The efficacy of Zulresso was shown in two clinical studies in participants who received a 60-hour continuous intravenous infusion of the drug or placebo, and were then followed for four weeks.
One study included patients with severe PPD and the other included patients with moderate PPD. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale.
In both placebo-controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion, the US Food and Drug Administration noted, adding that the improvement in depression was also seen at the end of the 30-day follow-up period.
The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing.
Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) “and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient,” confirmed Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.