Drug Approvals

Sage Therapeutics wins first FDA postpartum approval

Mar 20, 2019

 The U.S. FDA has approved Sage Therapeutics' Zulresso, the first drug approved by the agency specifically to treat postpartum depression.

The intravenous injection 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.

Zulresso is administered as a continuous IV infusion over a total of 60 hours. Sage said it will cost $7,450 per vial, or $34,000 for a patient’s average course of therapy -- before any discounts.

Sage is also developing a pill formulation of the drug.

Read the FDA release
Read about Sage's trial results

Want to get content like this in your inbox?  Subscribe to our eNewsletter here!