Food and Drug Administration announced the first drug specifically that treats postpartum depression in new mothers.
FDA says, Brexanolone with brand name Zulresso is delivered as intravenous infusion over 60 days course. The drug that works within two days, costs $20,000.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child”
FDAapproves first treatment for post-partum depression: https://t.co/znZdsKWTPX.
Centers for Disease Prevention & Control predicts that postpartum depression impacts one in nine women nationally.
According to National Institute of Mental Health, medication & counseling currently treat postpartum which can take weeks to work.
Untreated postpartum depression lasts for months or even years.
Zulresso will be available from certified health care facilities only by a restricted program which is called “Zulresso REMS Program”.
CEO of Sage Therapeutics, Jeff Jonas which developed Zulresso stated that drug will only be available in June.
“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”
For the first time in history, the US Food and Drug Administration has approved a drug specifically indicated for the treatment of postpartum depression, which experts say offers new hope to women and physicians. The FDA announced the approval of an intravenous infusion of the drug brexanolone, which will be sold as Zulresso.