Breakthrough treatment for postpartum depression.
PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy 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. Experts believe the prevalence of postpartum depression could be at least twice as high as what current statistics reveal because many cases go undiagnosed. Counseling and antidepressant medications are primary treatments, but some women do not respond to these therapies.
In 2019, the FDA approved an intravenous infusion treatment to treat postpartum depression specifically. This novel therapy, administered around the clock for 60 hours, uses a neurosteroid to control the brain’s response to stress. This treatment design is groundbreaking as it targets the signaling thought to be deficient in hormone-sensitive postpartum depression. Additionally, this treatment appears to show benefits very quickly, while traditional antidepressants typically take two to four weeks to have a significant effect. This rapid treatment option would be a breakthrough for women with this often overlooked condition.
“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. "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." Approval of Zulresso was granted to Sage Therapeutics, Inc.
(https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-post-partum-depression ) ( https://www.empr.com/home/news/drugs-in-the-pipeline/trial-evaluating-zuranolone-for-postpartum-depression-meets-all-endpoints/ )





